Since its founding in 1949, AGG has represented manufacturers, distributors and service providers in the food, pharmaceutical, biotechnology and medical device industries that are regulated by the U.S. Food and Drug Administration and other governmental agencies.
The firm represents companies of all sizes, ranging from start-ups to multinational companies and privately-held and publicly-traded corporations.
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, Good Manufacturing Practice Requirements, regulatory strategies and life cycle management, 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 and submits comments to FDA proposals and prepares citizen petitions. The firm also conducts in-house training for clients. 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 U.S. Department of Agriculture, the Alcohol and Tobacco Tax and Trade Bureau, the Consumer Product Safety Commission, the Drug Enforcement Administration, the Federal Trade Commission and the U.S. Customs and Border Protection.
For more information on this practice area, contact
