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

I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues is a legal podcast hosted by Arnall Golden Gregory LLP. In this podcast series, different members of our Food & 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 matters.

 

Episode 8: Business Divorces in the Food and Supplements Space

In this episode, Michael E. Burke, partner and co-chair of the Pharmaceutical & Biotechnology industry team is joined by Robert Durkin, an attorney in our Dietary Supplements team, as they discuss issues around business divorces or disputes between companies in the food and supplements space. They will discuss, among other things, post-divorce product regulatory status and related business challenges, as well as strategies that can be employed at the beginning of the business relationship to help mitigate risk if the relationship goes bad.

Episode 7: Fee Waivers for Small Businesses: Who Qualifies for the Small Business User Fee Waiver for Drugs and Biologics and How to Apply from an FDA and Corporate Perspective

In this episode, AGG’s Food & Drug team leader, Alan G. Minsk, and Genevieve M. Razick, an attorney in our Healthcare and Food & Drug practices, along with Leah D. Braukman, an attorney in our Corporate & Finance practice, discuss the specifics of the small business user fee waiver, who qualifies, and how to apply from an FDA and corporate perspective.

 

Episode 6: Data Privacy Issues Life Sciences Companies May Encounter

In this episode, AGG’s Food & Drug team leader, Alan G. Minsk, and co-chair of AGG’s Data Privacy practice, Kevin L. Coy, discuss U.S. and international privacy and data security law issues life sciences companies may encounter such as privacy policies, the patchwork of federal and state privacy and data security laws in the U.S., international data protection laws, such as GDPR, and related international data transfer issues.

 

Episode 5: FDA Regulation of Rx Drug and Medical Device Advertising and Promotion: 2020 Year in Review

In this episode, AGG’s Food & Drug team leader, Alan G. Minsk, and team member, Genevieve M. Razick, give an overview of FDA’s Office of Prescription Drug Promotion’s (OPDP) enforcement of unlawful advertising in 2020.

 

Episode 4: FDA Regulated Natural Products: Leveraging IP and Regulatory Requirements to Maximize Possible Return on Investment

AGG Dietary Supplements team leader Kevin M. Bell and team member Robert Durkin discuss some of the more interesting issues and challenges they have encountered when working with clients to ensure they maximized opportunities to monetize the greatest value from their natural products and how a well thought out and executed regulatory strategy can help.

 

Episode 3: Pandemic Marketing 101: Do’s and Don’ts to Market Your Brands, Products, and Services Safely

AGG partner Anuj Desai and of counsel Carolina M. Wirth discuss the Federal Trade Commission (FTC) and Food and Drug Administration’s (FDA) roles of protecting consumers at the height of a public health crisis and the types of advertising and legal compliance issues that have surfaced in the past several months as well as provide a recap of agency actions.

 

Episode 2: Key Due Diligence Issues to Consider When Acquiring or Investing in Life Sciences Companies or Products

In our second episode, Alan Minsk and Brian A. Teras cover key due diligence issues to consider when acquiring or investing in life science companies or products. They provided an overview of the diligence process, potential red flags, common mistakes, and other factors to consider during the due diligence process.

 

Episode 1: Quality Agreements for FDA-Regulated Products: Looking Under the Hood

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 & Biotechnology 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.

 

Stay tuned for more from AGG’s Food & Drug team on this channel.