Food, Drug, Device, Biologic & Cosmetic

Our nationally-recognized team advises food, drug, medical device, biologic, and cosmetic companies on all issues relating to their industries’ regulation by federal and state authorities.

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.

I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues Podcast Series

Each month, we will release a new podcast where different members of our Food and Drug practice and colleagues in other related life science teams will discuss issues and challenges they have encountered when assisting clients on business and legal issues. In our inaugural episode, Alan G. Minsk, partner and leader of the Food & Drug practice team, is joined by Michael E. Burke, co-chair of the Pharmaceuticals & Biologics industry team, and the administrative partner of the firm’s D.C. office, as they discuss issues around quality agreements for FDA-regulated products as well as topics related to manufacturing, FDA timelines and compliance with relevant national authorities.

To view the podcast, please click here.

Experience

Our Food and Drug team provides daily counseling on a wide variety of regulatory issues. AGG is unique in that it can provide a number of services to our pharmaceutical and biotechnology clients beyond merely the FDA-related work. Therefore, rather than list representative “experiences” that any reputable food and drug practice can provide, which we do daily, the following is merely some recent examples where our Food and Drug team and other AGG practice groups assisted our clients.

 

  • Serve on a dozen Promotional Review Committees for companies with either FDA-approved products or products in the investigational stage; we serve as the legal representative to ensure compliance with FDA requirements, but lawyers in our Healthcare, Data Privacy, and Trademark practices often assist, as needed.
  • Draft a number of agreements, such as Product Development and Collaboration, Manufacturing and Supply, Distribution, Intellectual Property License, Website Development, Website Terms and Conditions, and E-commerce for a contract manufacturer of over-the-counter pharmaceutical and dietary supplement products. AGG’s Food and Drug and Corporate practices jointly counsel this client.
  • Represented PL Developments in its acquisition of Teva Pharmaceuticals’ U.S. over-the-counter drug store-brand portfolio and a manufacturing facility. The deal involved lawyers from AGG’s Food and Drug, Corporate, and Tax practices.
  • Provided regulatory assistance to HealthEdge Investment Partners in its acquisition of WraSer Pharmaceuticals and Xspire Pharma to consolidate into a new company. Members of AGG’s Food and Drug and Healthcare practices assisted in the transaction.
  • Served as regulatory counsel to Sebela Pharmaceuticals in its acquisition of Braintree Laboratories, a leader in the gastroenterology pharmaceutical market. Members of AGG’s Food and Drug and Healthcare practices assisted in the transaction.
  • 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 practices were involved in this project.
    Client Successes

    Recognition

    Chambers USA recognizes AGG as a nationwide leader in the area of Life Sciences and Alan Minsk is ranked individually.

    News & Insights

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      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.

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