Alan G. Minsk 404.873.8690 [direct] 404.873.8691 [fax] alan.minsk@agg.com Area of Practice Food and Drug Law

Alan Minsk is a Partner and Leader of the Food & Drug Practice Team of Arnall Golden Gregory LLP. Mr. Minsk advises pharmaceutical, medical device, and food companies on all legal and regulatory matters relating to the U.S. Food and Drug Administration, and certain matters concerning the U.S. Department of Agriculture, the Federal Trade Commission, the Drug Enforcement Administration, the Bureau of Alcohol, Tobacco and Firearms, and the Consumer Product Safety Commission. He has spoken and written on a wide variety of FDA-related issues, including FDA enforcement authority and actions, FDA inspections, corporate compliance, Waxman-Hatch exclusivity, pediatric exclusivity, regulation of dietary supplement, medical device and pharmaceutical product promotion and advertising, product liability, human tissue regulation, protection of confidential information, financial disclosure by clinical investigators, imports and exports, and informed consent.

Professional Activities

• Georgia Chapter Leader, Regulatory Affairs Professionals Society
  
• Member, Georgia Biomedical Partnership
  
• Member, Food and Drug Law Institute
  
• Member, American Society for Pharmacy Law
  
• Member, State Bar of Georgia
  
• Member, American-Israel Chamber of Commerce (Southeast Region-Medical Committee)
  
• Member, Tennessee Biotechnology Association
  
• Member, Drug Information Association
  
• Editorial Advisory Board, Pharmaceutical Formulation & Quality
  
  
Publications

• Author: "Final Compliance Program Guidance for Pharmaceutical Manufacturers," AGG Life Sciences Alert, May 2003.
• Author: "Counter Culture: FDA's newly issued final monograph for OTC combination products is set in motion," Pharmaceutical Formulation & Quality, April/May 2003.
• Author: "Confidentiality Protection In An FDA Environment: Can You Keep A "Secret" Secret?," American Pharmaceutical Outsourcing, January/February 2003.
  
• Author: "Looking Under the Hood and Kicking the Tires," Pharmaceutical Formulation & Quality, December 2002/January 2003.
  
• Author: "The Ongoing Off-label Challenge," Pharmaceutical Resource, Winter 2003.
  
• Author: "Ouch, That's Going to Leave a Mark," Pharmaceutical Formulation & Quality, August/September 2002.
  
• Author: "Off-label Promotion of Biotech Products: Is it Worth the Risk?," The National Law Journal, June 2002.
  
• Author: "Come Out, Come Out Wherever You Are: The Food and Drug Administration's Proposed Rule on Establishment Registration and Listing for Manufacturing of Human Cellular and Tissue-Based Products," Tissue Engineering, Winter, 1998.
  
• Co-Author: "FDA Export Reform and Enhancement Act of 1996: Exporting Unapproved Products for Investigational Use and Exporting Misbranded/Adulterated Approved Products," Food, Drug, Cosmetic and Medical Device Law Digest, September, 1998.
  
• Co-Author: "FDA Regime for Off-Label Use Emerges," The National Law Journal, August 31, 1998.
  
• Author: "The Food and Drug Administration's Proposed Rule on Establishment Registration and Listing for Manufacturers of Human Cellular and Tissue Based Products," Food, Drug, Cosmetic and Medical Device Law Digest, May, 1998.
  
• Author: "Legal Challenges for FDA and New Opportunities for Drug Companies: Market Exclusivity Revisited," Regulatory Affairs Focus, May, 1998.
  
• Author: "The Mammography Quality Standards Act of 1992: FDA's Final Implementing Regulations Prompt A Revisit," Food Drug Cosmetic And Medical Device Law Digest, 1998.
  
• Author: "To Grant or Not To Grant (180 Days of Market Exclusivity): That is FDA's Question," Regulatory Affairs Focus, December, 1997.
  
• Author: "FDA Reform Revisited: Regulation of Human Tissue," Tissue Engineering, Summer, 1997.
  
• Co-Author: "No Safe Harbor for Generic Drugs," Chemtech, 1996.

Education
B.A., Brandeis University, 1989 (summa cum laude; highest honors in politics)
J.D., Georgetown University Law Center, 1992 (member, Law & Policy in International Business)

Admitted to Practice
State of Georgia, 1992
Supreme Court and Court of Appeals of the State of Georgia, 1993
United States District Court for the Northern District of Georgia, 1997