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.
PODCAST SERIES:
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I Wish I Knew What I Know Now: Conversations With AGG on FDA Issues
Join the Food & Drug practice and colleagues in other related life science teams as we discuss issues and challenges we have encountered when assisting clients on business and legal matters. To access our podcast episodes, please click here.
Experience
Our Food & 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 are merely some recent examples where our Food & 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 & 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 & 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 & 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 & 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 & Drug and Corporate practices were involved in this project.
- 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
- 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 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 Present at Q1 Productions Pharmaceutical Regulatory Operations & Submissions ConferenceDecember 5 - 6, 2023 | Speaking Engagements | Arlington, Virginia
- EventsBob Durkin and Rich Cleland to Present NPA Webinar on Inner Workings of FDA and FTCDecember 6, 2023 | Speaking Engagements
- PublicationsI Can See Clearly Now: FDA Issues Final Rule on DTC Rx Ads Relating to Presentation of the Major Statement in TV and Radio FormatNovember 30, 2023 | Alerts | Articles | Arnall Golden Gregory LLP
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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.
- Robert Durkin
Partner
- Alan G. Minsk
Partner
