Our FDA-regulated clients include pharmaceutical, medical device, food, cosmetic, and biologic companies of all sizes, from start-up to multinational businesses, many of which are traded on NYSE, NASDAQ, and foreign-trading exchanges. We work with companies representing all therapeutic and consumer product areas.
With a client base of hundreds of companies throughout the United States and a number based outside of the U.S., we are known for our pragmatic, creative, and cost-efficient approach to client work. In addition, with lawyers on our team who previously worked at the Food and Drug Administration, we are able to provide clients with an insiders’ view of the regulatory process. We pride ourselves on balancing regulatory objectives with each client’s real-world business considerations to identify and implement the best holistic solution possible.
We help companies navigate the FDA-regulatory process from initial clinical trial development to product approval, product promotion, post-approval requirements, and management. Merely as examples, our lawyers work on orphan drug matters, Breakthrough Therapy Designation requests, clinical trial agreements, quality agreement reviews, import/export issues, Citizen Petition inquiries or market exclusivity and patent certification questions, pharmacy compounding issues, combination product jurisdictional questions, and Good Manufacturing Practice-compliance matters.
Our attorneys help clients on corporate transactions involving FDA-regulated products. We prepare Regulatory Opinion Letters for securities filing and those regulatory sections involving FDA regulation and regulatory risks. We also conduct due diligence on potential investments, product or company acquisitions, co-promotion, licensing and distribution agreements, and other commercial transactions.
We advise clients with federal and state compliance and enforcement issues, and we counsel on related issues that affect the industry, such as privacy, fraud and abuse, state gift reporting, and trademarks and copyright laws. Clients also trust our advice on regulatory matters involving the Drug Enforcement Administration, the Federal Trade Commission, as well as State Boards of Pharmacy and other state regulatory bodies.
We have decades-long strong relationships with the FDA-regulated industries and we are committed to maintaining these relationships for decades to come. We currently serve as general counsel to the Sharing Alliance, Inc. (formerly the PDMA Alliance) and counsel to the Natural Products Association. Our attorneys are founding members of Georgia Bio (Georgia’s Life Science trade association) and lecture at universities and programs sponsored by the Food and Drug Law Institute and the Regulatory Affairs Professionals Society. In addition, our attorneys serve on the editorial boards of three national FDA and regulatory periodicals, and on the board of the National Health Museum. We are also recognized by leading rankings institutions, including Chambers USA, Who’s Who in Legal Life Science, and The Best Lawyers in America®.
- AGG Assists in $127 Million Sale of Ohio Medical to ESAB
- AGG Served as U.S. Counsel in Bora’s Landmark Acquisition Boosting Its Position as a Global Supply Chain Partner
- AGG's Due Diligence of FDA Regulations Aids ARS Pharmaceuticals in Improving Treatment for Severe Allergic Reactions
- Clearside Biomedical – FDA Regulatory Review Helps Company in its Successful IPO
- WellSpring Pharmaceutical Corp. USA – AGG Helps Facilitate Bactine Acquisition
- Medicines360 – Framework Created to Distribute Birth Control Device in Sub-Saharan Africa
- UPPI, LLC – FTC Cracks Down on Anti-Competitive Tactics Harming Client
- Theratechnologies - AGG Handles Pressing Assignments in a Timely and Cost-Effective Manner
- AGG’s “Business Sensible” Approach Successfully Guides Large Spanish Life Sciences Company Through High-Value Acquisition of US Pharmaceuticals Company
- Israeli Pharmaceutical Company - Public Listing Furthers Mission to Produce Highest Quality Life-saving Therapeutics
- Biotechnology Start-up Company - Clearing Logjam at FDA Allows Product Review to Resume
Chambers Global recognizes AGG’s Life Sciences practice as a leader among more than 200 jurisdictions across the world in the Life Sciences Regulatory and Compliance category. Alan Minsk is also ranked individually in the Life Sciences Regulatory and Compliance – USA category.
News & Insights
- EventsAlan Minsk to Speak at 2023 FDLI Annual Conference on FDA Inspectional Tools and Enforcement ActionsMay 18, 2023 | Speaking Engagements | Washington, DC
- EventsAlan Minsk to Present PDMA 101 at the 2023 Sharing Alliance™ ConferenceApril 30, 2023 | Speaking Engagements | San Diego, California
- EventsAlan Minsk to Speak at the Q1 Productions 6th Annual Medical & Regulatory Writing for Product Approvals ConferenceApril 27, 2023 | Speaking Engagements | Arlington, Virginia
Food & Drug Newsletter
Arnall Golden Gregory LLP’s Food & Drug Newsletter is a roundup of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from colleagues in other related life sciences disciplines.
- Michael E. Burke
- Alan G. Minsk