Food & Drug

Since its founding in 1949, AGG has represented manufacturers, distributors and service providers in the food, pharmaceutical and medical device industries that are regulated by the U.S. Food and Drug Administration and other governmental agencies.

A significant part of the firm’s food and drug law practice is devoted to counseling clients concerning statutory and regulatory requirements, particularly with regard to product approval and safety issues, GMPs, labeling, advertising, import/exports, clinical investigation requirements, product liability, market protections (e.g., Waxman-Hatch exclusivity, orphan drugs, and patent term extensions), and enforcement issues. The firm prepares compliance manuals and guidelines tailored to the practices and circumstances of particular clients and industries. In addition, the firm has a comprehensive food and drug law litigation practice, and lawyers in this practice group appear regularly before state and federal courts and administrative agencies. The firm also monitors current food and drug law legislation and regulatory developments.

Frequently in this area of practice, client goals and problems require solutions that involve diverse areas of the firm’s expertise. When consistent with a client’s needs, the firm applies a multidisciplinary approach that draws upon the resources and capabilities of various other practice groups, including antitrust and trade regulation, environmental, technology, health care, intellectual property, licensing, corporate finance, securities and tax. The firm also advises clients on matters regulated by the US Department of Agriculture, the Bureau of Alcohol, Tobacco and Firearms, the Consumer Product Safety Commission, the Drug Enforcement Administration, the Federal Trade Commission and the US Customs Service.

News & Events > Alan Minsk was quoted in the Pharmaceutical Resource a Campbell Alliance Publication an article titled "The Ongoing Off-Label Challenge," Winter 2003 edition.AGG sponsored the Georgia Summit on Entrepreneurship, March 20-21 at the Tifton Campus Conference Center, Rural Development Center, hosted by ENet and GEDA Committee's on Entrepreneur and Rural Development. > Alan Minsk spoke at the "Change Control for Biopharmaceutical Manufacturing" seminar March 10-11, his topic "Examine the FDA's Inspectional Authority and Enforcement Tools for Change Control." > Alan Minsk was quoted in the The Gray Sheet, a national weekly publication for the medical device industry, in an article about FDA's enforcement in the device promotion area on Februay 3. > Alan Minsk has been named to the Editorial Advisory Board for the Pharmaceutical Formulation & Quality journal. With this, he will write three articles for the magazine a year. > Arnall Golden Gregory Launches Nanotechnology Practice (press release)

Publications > FDA's newly issued final monograph for OTC combination products is set in motion. > Final Compliance Program Guidance for Pharmaceutical Manufacturers - May 2003 > Confidentiality Protection In An FDA Environment: Can You Keep A “Secret” Secret? - January/February 2003 > The Ongoing Off-Label Challenge Keeping physicians informed without “crossing the line” - Winter 2003 > Looking Under the Hood and Kicking the Tires One view of FDA’s new pharmaceutical cGMP initiative. - December 2002 / January 2003

Representative Clients > > > > > Perrigo Company Chattem, Inc. Novartis Ophthalmics Shire US Inc. Andrx Corporation

Related Practice Areas > > > Life Sciences Healthcare HIPAA Compliance