Food, Drug, Device, Biologic & Cosmetic
Overview
Our clients are diverse, based in and outside the U.S., ranging from early-stage startups to NASDAQ and NYSE-traded multinational firms. We concentrate on providing practical solutions and pride ourselves on being nimble and responsive in helping clients anticipate and overcome challenges and capitalize on opportunities.
We routinely represent clients before the U.S. Food and Drug Administration and the other federal and state regulatory bodies. We counsel clients on issues relating to product development and approval, clinical trials, labeling and advertising, product lifecycle management, regulatory due diligence, compliance and inspections, to name a few. We often collaborate with other AGG professionals whose expertise extends our capabilities even further, including attorneys from corporate, intellectual property, healthcare, government investigations, and logistics and transportation. This multidisciplinary approach has enabled us to become our clients’ trusted partner, because we are able to address the highly complex legal issues they face in the context of their unique business needs.
To learn more about our sub-practices, please proceed to our dedicated pages listed below.
We currently serve as General Counsel to the Sharing Alliance, Inc. (formerly known as the PDMA Alliance, Inc.), and our attorneys are founding members (and are Board members) of GeorgiaBio (Georgia’s Life Science trade association). They have taught food and drug law at Emory University School of Law and lectured at programs sponsored by the Food and Drug Law Institute and the Regulatory Affairs Professionals Society. Our attorneys also serve on the editorial boards of a number of national FDA and regulatory periodicals, and sit on the Board of the National Health Museum. We are also recognized by leading rankings institutions including Chambers, USA, Who’s Who Legal (Life Sciences) and Best Lawyers.
Experience
- Advised in the formulation of a strategic alliance between a large pharmaceutical company and our client, an emerging drug company, to develop license and market a generic product for the treatment of pediatric epilepsy. AGG’s Food and Drug and Corporate Teams were involved in this project.
- 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
- Thorough Due Diligence Facilitates Investment Deal
- Theratechnologies - AGG Handles Pressing Assignments in a Timely and Cost-Effective Manner
- 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
Recognition
Chambers USA recognizes AGG as a nationwide leader in the area of Life Sciences and Alan Minsk is ranked individually.
News & Insights
- PublicationsA Very Fine Line — Split Decision: FDA Issues Draft Guidance on Clinical Decision Support SoftwareNovember 26, 2019 | Alerts | Arnall Golden Gregory LLP
- PublicationsDéjà Vu All Over Again: OPDP Sends Another Letter Regarding Website Promotion of an Investigational New DrugNovember 25, 2019 | Alerts | Arnall Golden Gregory LLP
- PublicationsA Day Late and a Dollar Short: After Repeated Notices from FDA about its Contract Manufacturers, FDA Sends Warning Letter to Distributor for Receiving and Distributing Adulterated OTC DrugsNovember 25, 2019 | Alerts | Arnall Golden Gregory LLP
Food & Drug Newsletter
The Food & Drug practice is pleased to bring you these timely updates on the issues currently affecting industries regulated by the U.S. Food and Drug Administration (FDA). We hope you find the information in these recent publications and the upcoming events useful.
- Alan G. Minsk
Partner