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Michael H. Hinckle

Fax +1.919.516.2115
Mr. Hinckle's practice focuses on counseling corporations and individuals on all aspects of FDA regulatory and corporate matters. His primary efforts are in the area of pharmaceutical, medical device, and tobacco product regulation as well as related corporate transactional activities. His experience includes serving as in-house General Counsel for an international pharmaceutical corporation with responsibilities for all legal activities, regulatory affairs, quality assurance, corporate compliance and litigation oversight. Mr. Hinckle’s experience also includes representing clients before the FDA, DEA, North Carolina Department of Agriculture and various State Boards of Pharmacy. He has supervised the filing of numerous ANDAs, 505(b)(2) NDAs, Citizen Petitions and other regulatory filings. His corporate transactional experience includes negotiation and drafting of licensing, supply, distribution, and asset purchase agreements related to FDA-regulated products.

Professional Background

Prior to entering private practice, Mr. Hinckle worked as a molecular biologist with the American Type Culture Collection.  He then represented various FDA-regulated companies in private practice for 7 years before becoming the Vice President and General Counsel for Synthon Pharmaceuticals, Inc., a position that he held for 5 years.  Mr. Hinckle is a former member of the Board of Directors for the Generic Pharmaceutical Association, a frequent lecturer on FDA related matters.

Professional/Civic Activities

  • Food and Drug Law Institute
  • North Carolina Regulatory Affairs Forum
  • Board of Directors, Generic Pharmaceutical Association (2003-2005, 2007-2009)

Speaking Engagements

  • “The Biosimilars Act—A Basic Introduction,” NC CED Biotech Forum, September 2010
  • “Analysis of the Commonwealth Brands and Teva Pharmaceuticals Cases,” Food and Drug Law Institute 2010 Annual Meeting, April 2010
  • "New Product Development," Campbell University School of Pharmacy, annual lectures on FDA regulatory matters, 2006-present
  • "Preparing for Paragraph IV Challenges - Generic Pre-suit Strategies," CBI, Paragraph IV Conference, October 2008
  • "Interpreting Forfeiture Provisions - An Analysis of Recent Cases to Increase Preparedness and Improve Product Strategy," CBI, Paragraph IV Conference, October 2008
  • "Generic Drugs," NC Reg. Aff's Forum, RAC Certification Course, August 2008
  • "Protecting the Pharmaceutical Asset," RTP Biotech Day, October 2007
  • "Generic Drugs - Patents and Market Exclusivity," Campbell University School of Pharmacy," April 2006
  • "Basic FDA Regulatory Law," Campbell University School of Pharmacy, January 2006