K&L Gates : Practices & Industries : Food, Drugs, Medical Devices and Cosmetics

Food, Drugs, Medical Devices and Cosmetics : Newsstand


	Dodd-Frank’s Whistleblower Bounties: An Effective Hotline May Keep You Out of Hot Water, Government Enforcement Alert, by Michael J. Missal, Matt T. Morley. September 7, 2010. The bounty provisions of the Dodd-Frank Act make it essential for companies to reassess the mechanisms that they make available for employees to report concerns about potential corporate wrongdoing. Dodd-Frank creates enormous financial incentives for employees to report such concerns to law enforcement authorities, and in this environment, disincentives to internal reporting of concerns about improper conduct may prove costly and problematic.



	K&L Gates Advises Knopp Neurosciences on $345 Million License Agreement for Lou Gehrig’s Disease Drug Candidate, August 19, 2010.



	Global Government Solutions 2010: Mid-Year Outlook, K&L Gates Publication, July 2010. In response to the shifting business and economic relationships worldwide, governments around the globe are actively increasing their involvement in the private sector. Effectively navigating the dynamic relationship between government and business has become a significant concern for organizations large and small. As a follow up to Global Government Solutions^SM 2010: The Year Ahead report, which published in January, members of the K&L Gates Global Government Solutions^SM initiative have issued a 2010 Mid-Year Outlook, highlighting significant developments over the first six months of the year, and providing further insight into government agendas in wide range of areas, including environmental and energy policies, the implementation of financial regulatory reform and healthcare initiatives, and the changing political landscape around the world.



	Criminal Enforcement Will Become Even More Aggressive for the Pharmaceutical and Medical Device Industries, Food, Drugs, Medical Devices and Cosmetics Alert, by Steven M. Kowal. June 29, 2010. Through a series of recent public statements, the government has indicated that it will ratchet up investigations and criminal prosecutions of the pharmaceutical and medical device industries. Substantial additional resources have been allocated and deployed to pursue more investigations and to expand the types of conduct that will be subject to intense scrutiny. Also, a theory of strict criminal liability will be used more frequently to secure convictions. This alert discusses the variety of public statements and their possible impact on the pharmaceutical and medical device industries.



	GIPSA Publishes Proposed Rule Providing Significant New Protections Against Allegedly Unfair, Fraudulent or Retaliatory Practices, Food, Drugs, Medical Devices and Cosmetics Alert, by Karl M. Nobert, Robert G. Hibbert. June 23, 2010. On Tuesday, June 22, 2010 the USDA's Grain, Inspection, Packers and Stockyards Administration (“GIPSA”) published a proposed rule in the Federal Register that would add new regulations under the Packers and Stockyards Act ("P&S Act") and provide significant new protections for producers against what it asserts are unfair, fraudulent or retaliatory practices. Responding to alleged concerns regarding fairness in the marketing of livestock and poultry, the proposal is intended to address the increased use of contracting in the marketing and production of livestock and poultry by companies and individuals subject to the Packers and Stockyards Act (“P&S Act”) and allows for more effective and efficient enforcement by GIPSA. The goal of the new rules are to level the playing field between packers, live poultry dealers, and swine contractors, and the nation’s poultry growers and livestock producers. GIPSA will be accepting comments on the Proposed Rule through August 23, 2010.



	This is a Test; This is Only a Test, Consumer Product Safety Alert, by Eric L. Stone. May 25, 2010. Nearly 21 months following passage of the Consumer Product Safety Improvement Act of 2008 (CPSIA), the Consumer Product Safety Commission (CPSC) issued its “15 month rule,”proposing new requirements for testing (including component testing) and labeling of consumer products. Given the enormity of the tasks CPSC was required to address under the CPSIA, and the impact of many of those efforts on devising a testing and certification scheme, even a mere 6 month delay may be viewed as a significant achievement. CPSC has given members of the public 75 days following publication of these proposals in the Federal Register to absorb and understand these significant proposals and to provide comments to CPSC for consideration before it issues final rules. Given that CPSC’s rules and the accompanying discussion near 250 pages, this summary is necessarily incomplete. However, it touches on some of the basic provisions and briefly considers their impact on regulated firms.



	Navigating Regulatory Pathways in Neurology and Psychiatry, The Neurotech Industry Investing and Partnering Conference, by Suzan Onel. May 21, 2010.



	Top 20 Food and Drug Cases, 2009 & Cases to Watch, 2010, published by the Food and Drug Law Institute, by Michael H. Hinckle, Carolina M. Heavner. April 2010. Michael H. Hinckle and Carolina M. Heavner co-authored a chapter on a recent tobacco case, Commonwealth Brands, Inc. et al. v. United States et al. in this FDLI publication which will be available in April 2010. Chapter (5) posted with permission from FDLI.



	Safety First, Improved Consumer Protection Presents Corporate Challenges, Risk Management, by Eric L. Stone. April 2010. Posted with Permission.



	When Does “Primarily” Not Mean “Primarily”?, Product Safety Letter, by Eric L. Stone. March 28, 2010. Posted with permission.



	Global Government Solutions 2010 - The Year Ahead, K&L Gates Publication, January 2010. 2009 brought a further transformation in the relationship between business and government. Regardless of political systems or philosophies, governments around the world became more dynamic and intrusive in response to the financial crisis. This 2010 Annual Report, prepared by members of the K&L Gates Global Government Solutions initiative, contains concise articles that seek to forecast likely government actions and priorities regarding a broad spectrum of topics.



	Heath Care Fraud, Abuse and Enforcement, K&L Gates Government Enforcement Review, by Jeffrey L. Bornstein, Laura A. Brevetti, Darlene S. Davis, Rebecca L. Dandeker, Michael DeMarco, Amy O. Garrigues, David M. Glynn, Leanne E. Hartmann, Fred D. Heather, Julia Reynolds Johnson, Mary Beth F. Johnston, Steven M. Kowal, Matt T. Morley, Suzan Onel, Raymond P. Pepe, Michael D. Ricciuti, Paul W. Shaw, Robert J. Sherry, Stephen G. Topetzes, Floyd R. Hartley. January 2010.



	CPSC Lifts Certification Stay for Products Subject to the PPPA, Food, Drug, Medical Devices And Cosmetics/Consumer Product Safety Alert, by Carolina M. Heavner, Eric L. Stone. January 19, 2010. In an action that requires a scorecard, the Consumer Product Safety Commission ("CPSC") issued a Federal Register notice on December 28, 2009 announcing what it will do when the existing stay of enforcement for third party testing and certification expires on February 10, 2010. See 74 Fed. Reg. 68,588 (December 28, 2009). While CPSC decided to extend its stays for some products, it announced that it was ending the stay on others, including those subject to the Poison Prevention and Packaging Act ("PPPA") (16 C.F.R. pt. 1700). Id.



	FSIS Supplemental Proposed Rule to Require Nutrition Labeling for Meat/Poultry, Food, Drugs, Medical Devices and Cosmetics Alert, by Robert G. Hibbert, Grace Murphy. December 21, 2009. On December 18, 2009, the USDA Food Safety and Inspection Service ("FSIS") issued a Supplemental Proposed Rule requiring nutritional labeling of major cuts of single-ingredient raw meat and poultry products, and ground or chopped meat and poultry products, unless an exemption applies.



	K&L Gates’ Global Government Solutions Help Businesses Deal with Government’s Expanding Role, October 21, 2009. K&L Gates has launched a Global Government Solutions initiative to assist clients in managing the threats and opportunities presented by government authorities around the world.



	Not So “Voluntary” Standards?, Consumer Product Safety Alert, by Eric L. Stone. October 14, 2009. At a meeting on October 7, 2009, the Consumer Product Safety Commission (“CPSC” or “Commission”) staff discussed with the Commission its plans to begin using its new authority under section 15(j) of the Consumer Product Safety Act (CPSA), 15 U.S.C. § 2064(j), as amended by section 223(a) of the Consumer Product Safety Improvement Act of 2008, Public Law 110-314, 122 Stat. 3016 (August 14, 2008) (CPSIA), to determine by rule that violations of voluntary standards for drawstrings in children’s garments and immersion protection in hair dryers present a “substantial product hazard.” Just like that, a voluntary standard can become mandatory, and non-compliance with such a “voluntary” standard may trigger seizures at ports, recalls, and possibly other enforcement action including civil and criminal penalties.



	FDA’s Reportable Food Registry, by Suzan Onel, Anthony T. Pavel. October 9, 2009. As of September 2009, food manufacturers have a new requirement. The Reportable Food Registry (RFR) is now operational.



	"Understanding Food Safety Strike Zones - Defining Adulteration Can Create Legislative Curve Balls", MEAT & POULTRY, by Robert G. Hibbert. October 2009. Linked with Permission. Registration required to access article.



	Reducing FCPA Risks for Pharmaceutical and Medical Device Companies Through Cost-Effective Compliance Strategies, Update Magazine, by Suzan Onel, Matt T. Morley. September/October 2009. Update Magazine 2009, Issue 5 With permission from FDLI



	Important Regulatory Developments: FDA's Reportable Food Registry and Other Reporting Obligations, K&L Gates Webinar, by Robert G. Hibbert, Steven M. Kowal. July 28, 2009. Though on the books for some time, the current FDA and USDA leadership are focusing on enforcement of existing reporting regulations for the food industry. Just last month, the FDA issued draft guidance on the Reportable Food Registry. Most importantly, compliance with the requirements of the Reportable Food Registry commences on September 8, 2009. Topics in this webinar included: FDA's Reportable Food Registry draft guidance and potential issues USDA reporting obligations and pending developments affecting meat and poultry Compliance with notification requirements included in the 2008 Farm Bill Enforcement issues and consequences for failure to report Training of line staff to ensure timely internal notice and investigation



	China's New Food Law: An American Perspective, China Legal Review, by Robert G. Hibbert, Grace Murphy. Article originally published in China Legal Review. Posted with permission.



	Reducing FCPA Risks for Pharmaceutical and Medical Device Companies Through Cost-Effective Compliance Strategies, Foreign Corrupt Practices Act (FCPA)/Food, Drugs, Medical Devices and Cosmetics Alert, by Matt T. Morley, Suzan Onel. June 11, 2009. Pharmaceutical and medical device companies doing business internationally face higher risks than many other companies of running afoul of the Foreign Corrupt Practices Act (FCPA), which prohibits payments to foreign government officials. While most companies may be attuned to these issues in the context of seeking regulatory approvals, many overlook the fact that these restrictions also extend to certain incentives that may be provided to persons employed by government-run hospitals, such as investigators, doctors and purchasing officers. The adverse consequences of an FCPA violation can be substantial, with monetary penalties, reputational damage, and restrictions on a company’s ability to export goods and participate in U.S. government programs. Companies can significantly reduce their risk of running afoul of these laws through several relatively simple and cost-effective steps.



	When Is a Pen Only a Pen?, Consumer Product Safety Alert, by Eric L. Stone. June 11, 2009. In a letter from the General Counsel of the Consumer Product Safety Commission (CPSC) dated June 4, 2009, CPSC helps those who have been struggling to understand how the agency interprets the “children’s product” definition in the Consumer Product Safety Improvement Act of 2008 (Public Law 110-314, 122 Stat. 3016, August 14, 2008) (CPSIA). According to the CPSC, mere marketing to children does not convert a pen into a children’s product, nor do novelty features necessarily do so.



	New U.S. Product Safety Law — New Challenges for Product Manufacturers, China Legal Review, by Eric L. Stone. Article originally published in China Legal Review. Posted with permission.



	On the hook: Under a new administration, some old food-safety issues loom at USDA, Meat & Poultry, by Robert G. Hibbert. June 2009. Posted with permission.



	Recall Rhapsody: The Consumer Product Safety Commission’s Proposed Recall Notice Rule, Product Safety & Liability Reporter, by Eric L. Stone. April 27, 2009. Posted with permission.



	Regulating the Conduct of Medical Device and Drug Manufacturers: Beware the Massachusetts Health Care Practitioner, Life Sciences Alert, by Suzan Onel, Ronda P. Moore. April 22, 2009. Massachusetts medical device and pharmaceutical companies will soon become subject to the most stringent sales and marketing activity regulation in the country. On July 1, 2009, a Massachusetts regulation entitled, “Pharmaceutical and Medical Device Manufacturer Code of Conduct” goes into effect. The regulation implements a 2008 Massachusetts law that requires companies to report to the state government the value, nature, purpose, and recipient of any payment or economic benefit to a health care practitioner that is valued at $50.00 or more. The regulation also: (1) enumerates prohibited conduct for sales and marketing activities, (2) mandates that certain gift, payment, and reimbursement activity be conducted under a formal written agreement, (3) requires the adoption of a code of conduct in compliance with the regulation, and (4) requires annual monitoring and certification of compliance. Penalties apply for each transaction that does not comply.



	FDA to Review Classification of 25 Medical Device Categories, FDA Alert, by Suzan Onel, Anthony T. Pavel. April 16, 2009. The Food and Drug Administration (“FDA” or the “agency”) announced the issuance of an order on April 8, 2009, requiring manufacturers of twenty-five (25) types of Class III preamendment medical devices to submit safety and effectiveness information to the agency by August 7, 2009. Affected device types include cranial electrotherapy stimulators, electroconvulsive therapy devices, intra-aortic balloon and control systems, implantable pacemaker pulse generators, implanted blood access devices, and shortwave diathermy and iontophoresis devices. A complete list appears below. Failure to comply with the FDA order could result in charges of misbranding and possible seizure, injunction, civil penalties, and criminal prosecution. See 74 Fed. Reg. 16214 (April 9, 2009).



	The Opportunity to Harmonize Human Subject Protection Regulations That Relate to hESC Research, BNA Medical Research Law & Policy Report, by Carol Pratt, Ph.D.. April 2009. Posted with permission.



	Recall Rhapsody: The Consumer Product Safety Commission’s Proposed Recall Notice Rule, Consumer Product Safety Alert, by Eric L. Stone. March 23, 2009. You’ve done everything right, but still “stuff happened.” Now you have to conduct a recall. What impact do the U.S. Consumer Product Safety Commission’s (CPSC) new recall notice proposals have on you and your recall planning?



	K&L Gates Expands FDA Practice Through Addition of Research Triangle Park Partner, March 19, 2009.



	Preemption of Drug Failure to Warn Claims:, Living in the Aftermath of Wyeth v. Levine, Food, Drugs, Medical Devices and Cosmetics/Health Care Alert, by Michael H. Hinckle, Lawrence C. Lanpher. March 16, 2009. On March 4, 2009, the U.S. Supreme Court in a 6-3 decision held that the labeling requirements of the Federal Food, Drug, and Cosmetic Act did not preclude the filing of a state law “failure to warn” tort claim. See Wyeth v. Levine, 555 U.S. _____ (2009). The FDA, represented by the Solicitor General, had pushed hard for a preemption ruling. In the absence of further action by Congress or the FDA establishing a clear conflict or express preemption, the Court’s decision makes clear that manufacturers can be liable for damages in state tort actions even if drugs are distributed using the FDA’s approved label. Although limited in many respects to the facts of the case, the Wyeth decision has implications for biopharmaceutical manufacturers, distributors of pharmaceuticals and biologics, and possibly retail, specialty and mail order pharmacies.



	Court Overturns Commission Position That Phthalate Prohibition Does Not Apply to Inventory; CPSC Rejects Lead Stay, Consumer Product Safety Alert, by Eric L. Stone. February 6, 2009. Yesterday, the United States District Court for the Southern District of New York overturned a decision by the Consumer Product Safety Commission that the Consumer Product Safety Improvement Act of 2008's new phthalate requirement applies only to products manufactured after February 10, 2009. On the eve of the new requirement, the Court's decision applies the law to all inventory. On Friday, February 6, the Commission also refused to grant an emergency stay of the lead ban. These eleventh hour developments have created a great deal of uncertainty and possible enforcement exposure for manufacturers, importers, distributors and retailers.



	Draft Guidance on Good Importer Practices: All You Need to Know, K&L Gates Webinar, by Eric L. Stone, Robert G. Hibbert, Rebecca L. Dandeker, Jerome J. Zaucha. February 5, 2009.



	CPSC Issues Stay on Testing and Certification, Consumer Product Safety Alert, by Eric L. Stone. February 3, 2009. Late on Friday, January 30, 2009, the Consumer Product Safety Commission posted on its web site a proposed Federal Register notice it calls “Notice of Stay of Enforcement of Testing and Certification Requirements” and an accompanying press release. This alert discusses the scope of this document and what the stay means for manufacturers, distributors, and retailers of children’s products.



	How Does the CPSIA Affect FDA-Regulated Industries?, K&L Gates Webinar, by Suzan Onel, Eric L. Stone. January 29, 2009.



	Cosmetics, Food and Drug Law and Regulation, published by the Food and Drug Law Institute, by Suzan Onel, Gary L. Yingling. December 2008.



	Getting It Right — Legal Issues to Consider When Choosing Sites in International Clinical Trials, RxTrials Institute audio conference, by Ann M. Begley. November 12, 2008. In an RxTrials Institute audio conference on November 12, 2008, K&L Gates Partner Ann M. Begley offered her insight on how to identify clinical sites around the globe that provide the quality and compliance you expect, as well as meet FDA standards — including the agency's latest rule on human subject protection standards.



	FDA Issues Final Rule on Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, Food, Drugs, Medical Devices and Cosmetics Alert, by Robert G. Hibbert, Carolina M. Heavner. November 12, 2008. On November 7, 2008, the Food and Drug Administration ("FDA") issued a final rule implementing the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 ("Bioterrorism Act"), which requires the submission to FDA of prior notice of food, including animal feed, that is imported or offered for import into the United States. See 73 Fed. Reg. 66294 (November 7, 2008).



	Room for Improvement – In the Wake of the Produce Industry’s Recent Food-Safety Debacle, the Onerousness on Processors has Perhaps Never Been More Evident, MEAT&POULTRY, by Robert G. Hibbert. September 2008. Linked with permission. Registration required to access article.



	Stem Cells: A Regulatory Overview, presented via webinar, by Karl M. Nobert, Gary L. Yingling. October 7, 2008. Relying on FDA's regulations for drugs and biological products, and FDA's July 2008 Warning Letter challenging a U.S. firm's marketing and promotion of stem cells for therapeutic applications, this presentation examined FDA's regulatory oversight of stem cells when used in humans and analyzed its potential impact on industry participants in the future.



	Research and the FDA, A Practical Guide to Food and Drug Law and Regulation - Third Edition, by Gary L. Yingling, Ann M. Begley. October 2008. Gary L. Yingling and Ann M. Begley, co-authored Chapter 16 entitled "Research and the FDA" in the Third Edition of A Practical Guide to Food and Drug Law and Regulation. The Third Edition of A Practical Guide to Food and Drug Law and Regulation has been significantly updated and revised from the Second Edition, including incorporation of the Food and Drug Act Amendments passed by Congress and other new laws passed since 2002. It also includes three new chapters: Combination Products, Pharmacovigilance, and Regulation of Medical Research. Practical Guide remains the single best resource for anyone needing a basic, uncomplicated understanding of the myriad requirements enforced by the Food and Drug Administration. Key points of Chapter 16 are: Each of FDA’s five substantive centers has its own requirements for research. Experimental animal research is regulated closely by both the PHS and the USDA to ensure the humane treatment of laboratory animals. In clinical research, the essential purpose of an institutional review board is to review research to assure it meets the ethical obligations of a clinical study, whereas the principal investigator controls the integrity of the research and manages the other professionals conducting the research and the sponsor must monitor the study and the principal investigator’s research to assure compliance. To assure that persons involved as subjects in a clinical study are properly informed, FDA requires that investigators obtain written informed consent from study subjects. When submitting data to FDA for review, a major consideration will be the integrity of the data. Click here to purchase the book.



	Mandatory Electronic Drug Establishment Registration and Drug Product Listing to Be Implemented June 1, 2009; Pilot Program in Place Now, Food, Drugs, Medical Devices and Cosmetics Alert, by Ann M. Begley, Anthony T. Pavel, Patrick N. Caldwell*. August 7, 2008. On Friday, July 11, 2008, the U.S. Food and Drug Administration (FDA) announced the availability of a draft guidance for industry entitled “Providing Regulatory Submissions in Electronic Format – Drug Establishment and Drug Listing.” 73 Fed. Reg. 39,964 (July 11, 2008). With publication of the draft guidance, FDA announced its plans to enforce new statutory requirements to compel electronic submission of drug establishment registration and drug product listing information. The agency will exercise enforcement discretion with respect to electronic submission until June 1, 2009, after which FDA plans to accept such information only electronically, unless a waiver is granted. The FDA draft guidance also communicated the launch of a voluntary Pilot Program that will enable industry to begin submitting drug establishment registration and drug product listing information in electronic format now in lieu of current FDA forms. Regardless of your firm’s decision as to participation in the voluntary Pilot Program, it will need to prepare for FDA’s planned mandatory implementation date of June 1, 2009. Please contact us if you would like additional information about the draft guidance and its potential impact on your firm. A link to the draft guidance is provided below: http://www.fda.gov/CDER/GUIDANCE/OC2008145(2).pdf.



	USDA Gets “COOL” – Certain Agricultural Commodities Must Bear Country of Origin Labeling by September 30, 2008, Food, Drugs, Medical Devices and Cosmetics Alert, by Robert G. Hibbert, Grace Murphy. August 5, 2008. As of September 30, 2008, a wide range of agricultural commodities will have to bear country of origin labeling (“COOL”) under USDA’s Agricultural Marketing Service Interim Final Rule. Covered commodities offered for sale must state their country of origin on their labeling, either in the form of a placard, sign, label, sticker, band, twist tie, pin tag, or other format that allows consumers to identify the country of origin. The Interim Final Rule, published in the Federal Register on August 1, 2008, can be viewed online at the following page: http://federalregister.gov/OFRUpload/OFRData/2008-17562_PI.pdf. A comment period will be open for 60 days following the August 1st publication, but compliance is still required beginning September 30, 2008.



	FDA Publishes Proposed Rule in Federal Register Classifying Certain Ingredients and OTC Product Categories as “Not Generally Recognized as Safe and Effective", Food, Drugs, Medical Devices and Cosmetics Alert, by Emalee G. Murphy, Rebecca L. Dandeker, Karl M. Nobert. July 2, 2008. On Thursday, June 19, 2008, the U.S. Food and Drug Administration (FDA) published aresponse to a 2003 Request for Data and Information in the form of a Proposed Rule. 73 Fed. Reg. 34895 (June 19, 2008). In the Proposed Rule, FDA proposes to classify certain over-the-counter (OTC) drug product categories and active ingredients as not “generally recognized as safe and effective” or as misbranded unless they are approved by FDA through the new drug approval (NDA) procedures.



	Time for Action - The Idea That FSIS Might Make Some Well-Reasoned Decisions About How to Handle the E.coli Mess is Neither Radical nor Controversial. It's Just Overdue, Meatingplace.com, by Robert G. Hibbert. June 2008. Linked with permission. Registration required to access article.



	Missed Opportunity, Meatingplace.com, by Robert G. Hibbert. May 2008. Linked with permission. Registration required to access article.



	Turf Tussle - Differing Listeria Guidelines Could Catch Processors Unawares, Meatingplace.com, by Robert G. Hibbert. April 2008. Linked with permission. Registration required to access article.



	Hallmark/Westland Recall, CC4F News, by Robert G. Hibbert. March 4, 2008. Linked with permission.



	Performance Anxiety - The Latest Salmonella Performance Standards From FSIS Could Embarrass Plants That Aren't Nearly Perfect, Meatingplace.com, by Robert G. Hibbert. March 2008. Linked with permission. Registration required to access article.



	Refrigerated or Frozen Ready-to-Eat Foods and Listeria Monocytogenes: FDA Issues Draft Enforcement Policy and Guidance for Industry, Food, Drugs, Medical Devices and Cosmetics Alert, by Robert G. Hibbert, Carolina M. Heavner. February 21, 2008. This Alert summarizes the Food and Drug Administration’s recent publishing of a Draft Compliance Policy Guide outlining the enforcement policy for Listeria monocytogenes ("L. monocytogenes") in ready-to-eat ("RTE") foods that support growth of the organism and RTE foods that do not, and a draft guidance for the industry providing specific guidance to food processors on the control of L. monocytogenes in the processing of RTE foods. The draft CPG presented by the FDA's Center for Food Safety and Applied Nutrition is intended to provide clear policy and regulatory guidance for FDA staff regarding L. monocytogenes in certain foods. Collectively these materials and this initiative also have implications for meat and poultry products regulated by USDA’s Food Safety and Inspection Service ("FSIS").



	Hallmark/Westland Recall, CC4F News, by Robert G. Hibbert. February 19, 2008. Linked with permission.



	Full Plate - When it Comes to Making Promises About Regulatory Actions, FSIS Has Eyes That are Much Bigger Than its Stomach, Meatingplace.com, by Robert G. Hibbert. February 2008. Linked with permission. Registration required to access article.



	On Notice - Notice 65-07 is a Useful Document - Even if it Won't Provide Much Relief for Processors, Meatingplace.com, by Robert G. Hibbert. January 2008. Linked with permission. Registration required to access article.



	Recalls Revisited - It Might be Time to Take the "Voluntary" out of USDA Recalls, Meatingplace.com, by Robert G. Hibbert. December 2007. Linked with permission. Registration required to access article.



	"Natural" Raising Claims for Livestock Products, Food, Drugs, Medical Devices and Cosmetics Alert, by Robert G. Hibbert, Grace Murphy. November 29, 2007. On November 28, 2007, the Agricultural Marketing Service ("AMS") published in the Federal Register a notice seeking comment on its proposed voluntary "naturally raised" marketing claim standard. See 72 Fed. Reg. 67,266 (November 28, 2007). The standard for a naturally raised marketing claim, if adopted, will be part of the voluntary U.S. Standards for Livestock and Meat Marketing claims. Please do not hesitate to contact Bob Hibbert at (202) 778-9315 or at for further information.



	So Long...For Now? - Off to Chase a Senate Bid, Mike Johanns Leaves Behind a Full Docket of Unfinished Business, Meatingplace.com, by Robert G. Hibbert. November 2007. Linked with permission. Registration required to access article.



	Broken Case Clarified, CC4F News, by Robert G. Hibbert. November 1, 2007. Linked with permission.



	Are Recalls Voluntary?, CC4F News, by Robert G. Hibbert. October 27, 2007. Linked with permission.



	Impact of New Dietary Supplement Rule on Current Good Manufacturing Practices (cGMPs), Food and Drug Alert, by Suzan Onel, Carol Pratt, Ph.D., Karl M. Nobert, Yi-Kang Hu, with the assistance of Michelle Bradbury, K&L Gates Summer Associate. October 16, 2007. The Food and Drug Administration (FDA) released its final rule on current Good Manufacturing Practices (cGMPs) for dietary supplements in June of this year, more than 10 years after the Advance Notice of Proposed Rulemaking was issued. For the first time, supplements will be distinguished from other food products and subject to their own distinct set of GMP requirements if sold or offered for sale in the United States. This Alert briefly summarizes the most notable provisions of the cGMP rule, particularly as it compares to the previously proposed rule and the current food GMP regulation, and also discusses some steps supplement companies can take to begin implementing the requirements.



	A Chilly Forecast - After Years of Anticipation, Debate and Delay, it Looks Like COOL is Finally Coming. Prepare to get Burned, Meatingplace.com, by Robert G. Hibbert. October 2007. Linked with permission. Registration required to access article.



	Special Concerns for Manufacturing and Marketing Functional Foods, presented at the ACI Conference on Dietary Supplements, Nutraceuticals and Functional Foods, by Suzan Onel. May 16, 2007.



	Building and Retaining Trust in the Biomedical Community, Cleveland Clinic Journal of Medicine, by Dick Thornburgh. March 2007. This article is the published version of Mr. Thornburgh's Keynote Address at the Cleveland Clinic’s “National Dialogue of Biomedical Conflicts of Interest.” The article focuses on the impact of maintaining the integrity of research, regulatory, and clinical institutions through effective management of potential conflicts of interest and disclosure. The talk focuses on four key relationships: 1) government and industry; 2) industry and the biomedical establishment; 3) the public and the biomedical establishment; and 4) product liability lawsuits and patient care. Posted with permission.



	Nanomedicines in Europe: An Opportunity for Investment, Nanotechnology Alert, by Rebecca Halford-Harrison, Barry M. Hartman, B. David Naidu. February 2007. Nanomedicines form the focus of an opinion released by the European Commission on 24 January 2007. The primary purpose of this opinion is to examine the regulatory systems relevant to nanomedicines. It highlights the opportunities for life science businesses expanding in or into Europe and provides the basis for a debate on how both regulatory and legislative frameworks for nanotechnology are developed.Nanomedicines in Europe: the Case for Regulation



	FSIS and FDA Policy on the Definition of “Natural” and the Qualification for Use on Food and Meat/Poultry Labeling, K&L Gates Food and Drug Alert, by Robert G. Hibbert, Grace Murphy. February 1, 2007. The regulatory definition and requirements for use of "natural" and "organic" claims have been difficult to pin down precisely. As public health awareness has increased and consumers demand healthier foods and the terms "organic" and "natural" have gained traction and appeal with the public, the demand for greater clarity in this area has increased. The United States Department of Agriculture’s Food Safety and Inspection Service ("FSIS") held a public meeting on December 12, 2006 in anticipation of rulemaking "to discuss the voluntary claim ‘natural’ and to delineate the conditions under which the claim can be used on the labels of meat and poultry products." See 71 Fed. Reg. 70,503 (December 5, 2006). The comment period for this meeting has been extended to March 5, 2007. The Food and Drug Administration ("FDA") also received a petition from the Sugar Association in February 2006 to codify the conditions under which a "natural" claim can be used. The attached article provides a brief history of "natural" and "organic" claims, describes FSIS and FDA's position on "natural" and "organic" claims, and provides strategies for companies to maneuver through the regulatory environment.



	Cloning – FDA Seeks Comments on the Safety of Consuming Meat and Milk from Cloned Animals, Food, Drug, Medical Device and Cosmetic Alert, by Robert G. Hibbert, Karl M. Nobert. January 2007. FDA recently released a series of draft documents assessing the potential human and animal health risks associated with consuming meat and milk products from cloned animals. The draft documents also evaluate the potential health risks to the cloned animals themselves. This alert discusses the legal issues behind cloning and FDA's recently released draft risk assessment, risk management plan and guidance.



	New Adverse Event Reporting Requirements for OTC Drugs and Dietary Supplements, Food, Drugs, Medical Devices and Cosmetics Alert, by Suzan Onel, Ann M. Begley, Anthony T. Pavel. January 2007. On December 22, 2006, President Bush signed into law the Dietary Supplement and Nonprescription Drug Consumer Protection Act, Pub. L. No. 109-462. This legislation requires for the first time marketers of dietary supplements and over-the-counter (OTC) drugs not subject to an approved NDA or ANDA to notify the FDA of serious adverse event reports associated with use of their products. Industry will have one year from December 22, 2006 to comply with the adverse event reporting, recordkeeping, and labeling requirements of the Act. Our K&L Gates FDA Alert provides further details about the new legislation and what it means for industry.



	FDA Drug Establishment Registration and Drug Product Listing Changes on the Horizon, Food and Drug Alert, by Ann M. Begley, Grace Murphy. December 2006. Client Alert to describe FDA's proposed changes to National Drug Code number assignment, potential impact on industry, and notice of public hearing.



	Representing Pharmacies and Pharmacists in State Licensing Board Proceedings, K&LNG Publication, by Raymond P. Pepe. November 2006. Proceedings before state pharmacy licensing boards may involve disciplinary proceedings, disputes regarding the issuance of licenses, certifications or approvals to individuals or facilities, and proceedings pertaining to the development of pharmacy board policies and regulations. The effective representation of pharmacies and pharmacists in these proceedings depends in large measure on the understanding and proper application of principles of state administrative practice and procedure unique to each of these types of proceedings as applied in the context of pharmacy law. This white paper addresses critical issues that should be considered when representing pharmacies and pharmacists in disciplinary proceedings.



	Nanotechnology - An Update on Business Opportunities & Regulatory Challenges, Environmental Alert, by Barry M. Hartman, Robert G. Hibbert, B. David Naidu. November 2006. Nanotechnology–the deliberate engineering of particles that are too small for the eye to see in order to create matter that has different properties than those at the conventional scale–has come of age. There are reportedly over 300 consumer products world-wide that contain some nanomaterials. This technology is present in products ranging from cosmetics (like sunscreen), to pollution remediation technologies, to semiconductors. Global sales of nanomaterials could exceed 1 trillion dollars before 2015. As with other scientific advances, this one may not fit neatly into current regulatory regimes designed to protect humans and the environment from a wide range of risks. This Alert gives a snapshot of how nanotechnology is currently regulated, and some of the issues that will be faced regarding how it may be regulated in the future.



	Cutting Through the Red Tape of Combination Product Approvals, Medical Design Technology Magazine, by Suzan Onel. October 2006. As the development and use of combination products increases, the FDA realizes it needs to establish specific guidelines to oversee this technology. This article explores some of the pivotal issues pertaining to how a combination drug-device, drug-biologic, or device-biologic is regulated. Posted with permission.



	K&LNG Expands Food and Drug Capabilities with Addition of New Partner, August 7, 2006. Robert G. Hibbert has joined K&LNG's Washington office in the firm's food and drug practice.



	FDA Encourages Submission Of NDAs For Marketed Unapproved Prescription Drug Products, While Signaling Continued Interest In Measured Enforcement Actions, Food and Drug Alert, by Rebecca L. Dandeker, Joshua Kim. June 2006. The U.S. Food and Drug Administration (“FDA”) recently bolstered its position as to Agency enforcement actions against marketed unapproved prescription drug products. In so doing, FDA (1) finalized its enforcement policy via a Guidance document titled, “Marketed Unapproved Drugs – Compliance Policy Guide”; (2) created an “Unapproved Drugs” Webpage containing links to important informational and policy documents; and (3) outlined a program to assist manufacturers in seeking approval of marketed unapproved prescription drug products via New Drug Applications, including the creation of an “Unapproved Drugs Coordinator” and the pronouncement of flexible clinical data requirements for such products. To highlight its commitment to the finalized enforcement policy, FDA took enforcement action against marketed unapproved prescription drug products containing the active ingredient, carbinoxamine.



	Multistate Investigations of the Pharmaceutical Industry, Food & Drug Law Institute Update, by Michael D. Ricciuti, John J. Farmer, Elizabeth M. Harris. March/April 2006. Amidst allegations of unlawful monopoly, patent abuse, and price-fixing, pharmaceutical companies have become particularly vulnerable to multistate investigations. With the increased costs of healthcare, state attorneys general (AGs) have focused their attention increasingly on "Big Pharma." The article presents various considerations pharmaceutical companies should weigh when faced with a multistate Attorney General investigation, because litigation sometimes is an appropriate course of action. As published in Update Magazine 2006, Issue 2. Reprinted with permission from FDLI .



	Postmarket Requirements for Significant Risk Devices, book chapter from Clinical Evaluation of Medical Devices, by Suzan Onel. 2006.



	Device 510(k) Premarket Notifications, presented FDLI’s Workshop on Introduction to Medical Device Law and Regulation: Understanding How FDA Regulates the Medical Device Industry, by Suzan Onel. January 26, 2006. This presentation offers guidelines on proceeding with 501(k) documentation.



	Dietary Supplements: A Definition that is Black, White, and Gray, American Journal of Law and Medicine, by Suzan Onel. 2006. This article describes the definition of a "dietary supplement" as distinguished from a drug or conventional food and explores the opportunities afforded by the definition for companies to position their products in the US marketplace.



	Proposed Changes to FDA and FSIS Food Standards, K&LNG Food & Drug Alert, by Suzan Onel, Vanessa W. Chandis. August 2005. The Food and Drug Administration ("FDA") and the Food Safety and Inspection Service ("FSIS") are the two federal agencies responsible for establishing standards of identity for food products. Food standards of identity assist consumers by standardizing the composition of certain foods, leveling the playing field for industry participants, and shielding manufacturers from the burden of having to meet different state requirements. Nevertheless, in recent years, manufacturers have expressed dissatisfaction with the existing standards of identity because many of the standards are outdated, stifle innovation, and are difficult to amend. Recognizing the value in having standards of identity, the two agencies have decided to propose a rule that establishes a general set of principles to modernize the food standards and provide a more uniform and efficient approach to creating, amending, or eliminating them. If finalized, this new set of principles would establish the criteria FDA and FSIS will use in evaluating a food standard petition. Both agencies seek comments to their proposed rule.



	Sunscreens: Regulations and Commercial Development, Chapter "The Final Monograph" by Emalee Murphy, edited by Nadim A. Shaath, Ph.D., Marcel Dekker and Taylor & Francis Group, by Emalee G. Murphy. 2005. Sunscreens, Third Edition covers: the role of organizations such as the FDA, the COLIPA, and the CTFA in the sunscreen industry; cosmetic formulations for water-proofing, SPF modulation, fragrancing, antiaging, and children and teens; products containing ultraviolet filters for the beach, daily wear, recreation, and occupational hazard protection; analytical testing procedures for sunscreens including in-vivo testing, UVA testing, and in-vitro assays;the emergence of antioxidants, botanicals, melanin, and other cosmeceuticals in the suncare industry. The Final Monograph chapter discusses the history and scope of the regulations, including key provisions of the final monograph, labeling requirements, sunscreen testing, labeling/advertising caveats for unwary marketers, and a look to the future.



	Do Recent Changes to DSHEA Put Supplement Companies at Risk?, Nutritional Outlook, by Emalee G. Murphy, Robert E. Feyder. April 2005. This article discusses regulatory and statutory changes to the Dietary Supplement Health and Education Act (DSHEA) that could increase the exposure of supplement manufacturers to lawsuits.



	The Ephedra Verdicts: What Do They Mean?, Nutrition Industry Executive, by Robert E. Feyder, Matthew G. Ball, Michael Mallow. March 2005. This article discusses recent litigation affecting the nutritional supplement industry and ways that the industry can reduce its litigation exposure. Posted with permission.



	Murphy's Law, K&L Food & Drug Newsletter, by Emalee G. Murphy. February 2005. Murphy's Law is a monthly update on regulatory, legislative, research and business developments for the FDA regulated industries of cosmetics, food, dietary supplements, over-the-counter pharmaceuticals and medical devices.



	Inside the Minds: Winning Legal Strategies for Biotech Companies, chapter in Guidelines to Follow for FDA Approval, by Gary L. Yingling. 2005.



	Murphy's Law, K&L Food & Drug Newsletter, by Emalee G. Murphy. July 2004. Murphy's Law is a monthly update on regulatory, legislative, research and business developments for the FDA regulated industries of cosmetics, food, dietary supplements, over-the-counter pharmaceuticals and medical devices.



	Life Science FOCUS, K&L Life Sciences Newsletter, multiple authors, March 2004. Life Sciences FOCUS is a periodic update on regulatory, legislative, research and business developments of interest to biotechnology, pharmaceutical, and medical device companies.



	Kirkpatrick & Lockhart Assists in Completion of $9.2 Million Financing for Hyalozyme Therapeutics, Inc., February 5, 2004. On February 3, 2004, the Los Angeles securities law practice of Kirkpatrick & Lockhart LLP (“K&L”) announced that it has assisted Grove Capital in the completion of a $9.2 million financing for Hyalozyme Therapeutics, Inc. (“Hyalozyme”). The financing also included an option to purchase an additional $15.9 million in warrants.



	Kirkpatrick & Lockhart LLP’s Washington Office Welcomes Five New Attorneys , January 14, 2004. K&L is pleased to announce the addition of partners Brian A. Ochs and Martin D. (Marty) Teckler, and three associates to our Washington, DC office. Mr. Ochs will enhance our nationally recognized securities enforcement practice and Mr. Teckler’s expertise is the perfect complement to our investment management, venture capital and capital markets groups.



	Get Ready for FDA's Bioterrorism Regulations – Requirements Become Effective December 12, 2003, Food and Drug Regulation Alert, by Suzan Onel. December 2003. The Food and Drug Administration ("FDA") recently issued two interim final rules ("IFRs") to help implement the Public Health Security and Bioterrorism Preparedness Response Act of 2002. The two IFRs implement the requirements that domestic and foreign food facilities register with FDA and that prior notice of imported food shipments be provided to FDA. The registration and prior notice requirements go into effect on December 12, 2003. This Alert summarizes some of the most significant aspects of the IFRs and their potential implications for manufacturers and importers of the affected products.



	Murphy's Law, K&L Food & Drug Newsletter, by Emalee G. Murphy. December 2003. Murphy's Law is a monthly update on regulatory, legislative, research and business developments for the FDA regulated industries of cosmetics, food, dietary supplements, over-the-counter pharmaceuticals and medical devices.



	Life Sciences FOCUS, K&L Life Sciences Newsletter, multiple authors, November 2003. Life Sciences FOCUS is a periodic update on regulatory, legislative, research and business developments of interest to biotechnology, pharmaceutical, and medical device companies.



	Murphy's Law, K&L Food & Drug Newsletter, by Emalee G. Murphy. September 2003. Murphy's Law is a monthly update on regulatory, legislative, research and business developments for the FDA regulated industries of cosmetics, food, dietary supplements, over-the-counter pharmaceuticals and medical devices.



	Recent Changes to FDA Patent Listing Rules, Food and Drug Regulation Alert, by Gary L. Yingling, Mark R. Leslie, Jesse Hirshman. July 2003. The Alert describes recent changes to FDA rules relating to the listing of Patents in connection with drugs and the ability of brand drug owners to delay approval of generic drugs.



	Kirkpatrick & Lockhart Attorneys to Speak at BIO 2003 in Washington, D.C., June 12, 2003. K&L attorneys will moderate and speak on two panels at the upcoming BIO 2003 conference, in Washington, D.C. from June 22 – 25, 2003. The panels will address the topics: “Drug Development Licensing: New Rules for an Old Game” and the “FDA’s Regulation of Electronic Records Under Part 11".



	Murphy's Law, K&L Food & Drug Newsletter, by Emalee G. Murphy. June 2003. Murphy's Law is a monthly update on regulatory, legislative, research and business developments for the FDA regulated industries of cosmetics, food, dietary supplements, over-the-counter pharmaceuticals and medical devices.



	Murphy's Law, K&L Food & Drug Newsletter, by Emalee G. Murphy. May 2003. Murphy's Law is a monthly update on regulatory, legislative, research and business developments for the FDA regulated industries of cosmetics, food, dietary supplements, over-the-counter pharmaceuticals and medical devices.



	Consumer Justice Center v. Olympian Labs: A Presumption Against Preemption, FDLI Update, by Matthew G. Ball. May/June 2003. This article analyzes a California case holding that the Federal Food Drug and Cosmetic Act, as amended by the Dietary Supplement Health and Education Act, does not preempt "private attorney general" actions under California's Unfair Competition Law.



	Murphy's Law, K&L Food & Drug Newsletter, by Emalee G. Murphy. April 2003. Murphy's Law is a monthly update on regulatory, legislative, research and business developments for the FDA regulated industries of cosmetics, food, dietary supplements, over-the-counter pharmaceuticals and medical devices.



	Murphy's Law, K&L Food & Drug Newsletter, by Emalee G. Murphy. March 2003. Murphy's Law is a monthly update on regulatory, legislative, research and business developments for the FDA regulated industries of cosmetics, food, dietary supplements, over-the-counter pharmaceuticals and medical devices.



	Murphy's Law, K&L Food & Drug Newsletter, by Emalee G. Murphy. February 2003. Murphy's Law is a monthly update on regulatory, legislative, research and business developments for the FDA regulated industries of cosmetics, food, dietary supplements, over-the-counter pharmaceuticals and medical devices.



	New User Fees and Label Requirements for Medical Device Companies - What Does this Mean for Industry, Food and Drug Regulation Alert, by Suzan Onel, Jodi Finder. January 2003. The Alert summarizes the provisions of the recently enacted Medical Device User Fee and Modernization Act of 2002, which amends the Federal Food, Drug, and Cosmetic Act by establishing a system of "user fees" for medical device applications, among other changes in the law. Authors' Note: On February 25, 2003, the U.S. Food and Drug Administration announced that it will begin collecting the user fees imposed by the Medical Device User Fee and Modernization Act of 2002 ("MDUFMA") (Pub. L. 107-250). See 68 Fed. Reg. 8773 (Feb. 25, 2003) Click here for viewing. Throughout March and April 2003, FDA will issue invoices for device notifications and applications submitted between October 1, 2002 and March 31, 2003, and will require payment within 30 days of those invoices. For device notifications and applications submitted on or after April 1, 2003, applicants will be required to pay the user fees upon submission.



	Murphy's Law, K&L Food & Drug Newsletter, by Emalee G. Murphy. January 2003. Murphy's Law is a monthly update on regulatory, legislative, research and business developments for the FDA regulated industries of cosmetics, food, dietary supplements, over-the-counter pharmaceuticals and medical devices.



	FDA Regulation of Medical Device Software: A Delicate Balancing Act, Journal of BioLaw and Business, by Suzan Onel. 2003. Computer software, when incorporated into or used with a medical device, becomes subject to FDA jurisdiction and regulatory authority. This article explores FDA's regulation of software as medical devices, specifically focusing on issues related to off-the-shelf software and computer software as components, parts, and accessories to other medical devices. FDA premarket submission requirements, electronic record and data integrity controls, hazard analysis, and FDA's enforcement initiatives are also discussed.



	Murphy's Law, K&L Food & Drug Newsletter, by Emalee G. Murphy. December 2002. Murphy's Law is a monthly update on regulatory, legislative, research and business developments for the FDA regulated industries of cosmetics, food, dietary supplements, over-the-counter pharmaceuticals and medical devices.



	Murphy's Law, K&L Food & Drug Newsletter, by Emalee G. Murphy. November 2002. Murphy's Law is a monthly update on regulatory, legislative, research and business developments for the FDA regulated industries of cosmetics, food, dietary supplements, over-the-counter pharmaceuticals and medical devices.



	Premarket Approval Applications (PMAs), Product Development Protocols (PDPs), and Humanitarian Device Exemptions, presentation to Food and Drug Law Institute’s Introduction to Medical Device Law and Regulation: Understanding How FDA Regulates the Medical Device Industry, by Suzan Onel. October 28-29, 2002. This session summarizes the requirements for a premarket approval application (PMA), FDA's standards for review, and the agency's review process.



	Investigational Device Exemptions (IDE), Clinical Trial Issues, and Medical Device Reimbursement, presentation to Food and Drug Law Institute’s Introduction to Medical Device Law and Regulation: Understanding How FDA Regulates the Medical Device Industry, by Suzan Onel. October 28-29, 2002. This session gives you the information necessary to assess when and whether an investigational device exemption (IDE) application needs to be filed with FDA as well as summarizes the the requirements for both the IDE application as well as the abbreviated IDE.



	Sponsor Responsibilities and Liabilities For Clinical Investigator Fraud, Pharmaceutical and Medical Device Law Bulletin, by Ann M. Begley, Suzan Onel. October 2002. The article uses a hypothetical case study to review the legal and ethical issues that may confront sponsoring companies in the event of breaches of protocol or fraudulent conduct by clinical investigators. Specifically, the article analyzes some situations in which sponsors are required to file reports with FDA, the potential liabilities inherent in not filing such reports and the importance of closely monitoring the activities of clinical investigators. This article is made available electronically with permission from American Lawyer Media.



	FDA Finalizes Rule That Could Expand OTC Drug Marketplace, FDLI Update, by Suzan Onel. September/October 2002. The article discusses a regulation recently issued by the U.S. Food and Drug Administration (FDA) that expands the criteria and procedures for over the counter (OTC) conditions to be included in OTC drug monograph systems. Permission to distribute this article has been granted by the Food and Drug Law Institute.



	Fraud & Non Compliance: Understanding When to Get the FDA Involved, Presented at the Center for Business Intelligence Forum on Preventing Non-Compliance in Clinical Research, by Ann M. Begley. July 29-30, 2002. This session gives you the information necessary to: Defining fraud and non-compliance and identifying instances that would create inquiry by FDA; Discuss responsibilities of the sponsor/CRO, the independent consultant and the investigator to report non-compliance/fraud; Explaining measures to minimize the effects of fraud/non-compliance on the product application; and Reviewing FDA’s response to fraud/non-compliance information.



	Drug Facts for Convenience-Size Packaging, Pharmaceutical & Medical Packaging News, by Gary L. Yingling. July 2002. The FDA has proposed Over the Counter (OTC) drug labeling regulations which make it almost impossible for firms to market one and two dose convenient package size containers normally available from vending machines or in gas stations, seven-elevens, airports and etc. The article suggests how FDA can address the labeling and regulatory issues and still allow the continued marketing of convenient size packages.



	Beware of Bioterror: New Legislation Affects Food, Drugs, and Medical Devices, Food and Drug Regulation Alert, by Ann M. Begley. July 1, 2002. Summarizes some of the most significant provisions in the recently passed new legislation, titled the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 as they apply to manufacturers, distributors, and importers of food, drugs, and medical devices.



	FDA Invites Public Comment on First Amendment Free Speech Debate, Food and Drug Regulation Alert, by Suzan Onel. May 2002. Discusses the Food and Drug Administration's recently issued Notice in the Federal Register seeking public comment on several First Amendment issues. This request for comment spans all areas regulated by FDA



	The Legal Nightmare for the Pharmaceutical Clinical Researcher: Examples of Cases and Concerns, SoCRA Source (Society of Clinical Research Associates), by Gary L. Yingling. May 2002. Provides an overview of clinical inspection activities by the Food and Drug Administration (FDA), the assurance process and compliance oversight of the Office of Human Research Protections (OHRP) in the Department of Health and Human Services (HHS), and private lawsuits against investigators.



	Section 11 of the Best Pharmaceuticals for Children Act-A Prelude to Reform?, Update, March/April 2002. The article considers the likelihood of significant reform of the law governing generic drugs in light of the recent passage of legislation closing a loophole used by brand drug companies to prevent generic competition.



	FDA Finalizes Rule That Could Expand OTC Drug Marketplace, Food and Drug Alert, by Suzan Onel. March 2002. Discusses a final regulation recently issued by the United States (U.S.) Food and Drug Administration (“FDA”) that expands the criteria and procedures for over-the-counter (“OTC”) conditions to be included in the U.S. OTC drug monograph system. This regulation may represent a significantly less expensive means than the traditional new drug approval (“NDA”) process for dietary supplement and cosmetic manufacturers to make therapeutic claims, as well as a potential avenue for expanded claims for the OTC drug industry.



	FDA Regulation of Medical Device Software, Prepared for the Institute for International Research’s Statistical Analysis for Pharmaceutical and Medical Device Manufacturing, by Suzan Onel. Computer software, when incorporated into or used with a medical device, becomes subject to FDA jurisdiction and regulatory authority. Ms. Onel's presentation focused on FDA's regulation of stand-alone software and off-the-shelf software; computer software as components, parts, or accessories to medical devices; complying with system validation and hazard analysis; and recent FDA enforcement initiatives related to software issues.



	Overview of Labeling and Advertising Claims, Presented at Dietary Supplements Workshop at the 2001 Annual Conference of the Regulatory Affairs Professionals Society, by Suzan Onel. November 4, 2001. Presents general label requirements, labeling and advertising claims, and potential liability related to dietary supplements.



	Functional Foods, Nutraceuticals, Designer Foods: What Are They and How Are They Regulated?, Regulatory Affairs Focus, by Suzan Onel. April 2001. This article summarizes the meaning and evolution of the terms "functional foods," "nutraceuticals," and "designer foods" and describes the FDA regulatory framework which applies to these products. In distinguishing the regulatory requirements for these products, Ms. Onel also discusses the safety and labeling requirements for conventional food products, medical food, and dietary supplements. Reprinted from the April 2001 issue of Regulatory Affairs Focus with permission of RAPS.

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