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

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Tell Me Lies, Tell Me Sweet Little Lies: FDA Is Not My Only Potential Headache When It Comes to Product Promotion

2023-03-2329:29

In this episode, Alan G. Minsk, AGG Food & Drug team leader, and Anuj Desai, AGG Intellectual Property partner and head of Trademarks, discuss recent developments that remind our audience in the food and drug space that FDA is not the only regulatory agency that’s keeping an eye on the marketplace. Alan and Anuj look at how NAD, a BBB program that supports advertising self-regulation, recently addressed a challenge in the prescription drug space. They also talk about how FTC investigative priorities in the past several months may be relevant to the food and drug/life sciences space.

Business Divorces in the Food and Supplements Space

2021-09-2723:13

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.

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

2021-06-2912:31

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.

Data Privacy Issues Life Sciences Companies May Encounter

2021-03-0119:47

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.

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

2021-02-0120:31

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.

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

2021-01-0139:58

In this episode, partner Kevin M. Bell and of counsel Bob 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.

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

2020-12-0128:51

In this episode, 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.

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

2020-11-0124:31

In this episode, Alan G. Minsk, partner and leader of the Food & Drug practice team, is joined by Brian A. Teras, partner of the Corporate & Securities practice team. They provide an overview of the diligence process, potential red flags, common mistakes, and other factors to consider during the due diligence process.

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

2020-10-0127:21

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. 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.

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