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

AGG is proud to introduce our newest podcast series titled “I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues.” 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.

• 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. To listen to the episode, please click here.

• 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 & 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.

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