Key Pharmaceutical Regulation Issues for the New Administration

Key Pharmaceutical Regulation Issues for the New Administration – FDA Watch

In our first episode, Shelly and Wayne chat with Nikki Reeves, Partner in the FDA & Life Sciences practice at King & Spalding, and Brian Malkin, Associate General Counsel for Regulatory Law at Teva Pharmaceuticals. You'll hear their thoughts on the top priorities in pharmaceutical regulation for the next FDA commissioner and their insights on AI policy, patient voices, and other front-burner issues. In our headlines segment, Shelly and Wayne delve into these major developments: Pharma: More than 200,000 Prescriptions for Wegovy Filled Devices: FDA Announces Communication Pilot on Recalls Food: Fruits & Vegetables: Are They Really Safe? Cosmetics: FDA Issue Final Rule on Color Additive Certification Fees In our Resource Links segment, we listed key documents in our fore core areas. To view these links, subscribe, or find out more information about our podcast, visit FDAWatch.net. Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at info@FDAWatch.net. Music by Dvir Silver from Pixabay.

Listen on Spotify

Listen on Apple Podcasts

In our first episode, Shelly and Wayne chat with Nikki Reeves, Partner in the FDA & Life Sciences practice at King & Spalding, and Brian Malkin, Associate General Counsel for Regulatory Law at Teva Pharmaceuticals. You’ll hear their thoughts on the top priorities in pharmaceutical regulation for the next FDA commissioner and their insights on AI policy, patient voices, and other front-burner issues.

Headlines

Pharma: More than 200,000 Prescriptions for Wegovy Filled

Devices: FDA Announces Communication Pilot on Recalls

Food: Fruits & Vegetables: Are They Really Safe?

Cosmetics: FDA Issues Final Rule on Color Additive Certification Fees. 

Resource Links

Pharma: FDA report: Upholding Public Trust: FDA’s Office of Criminal Investigations Critical Role in Bringing Drug Criminals to Justice

Devices: FDA Group white paper: Preparing for the FDA’s Quality Management System Regulation (QMSR)

Food: FDA request for information on PFAS in seafood

Cosmetics: PCPC’s announcement of its 2025 regulatory and legal conference

About Our Guests

Nikki Reeves

Nikki Reeves is a partner at King and Spalding. Nikki is an FDA and healthcare regulatory compliance lawyer with more than 25 years of experience. 

Nikki co-chairs the firm’s Government Matters & Regulatory practice management group, which is comprised of more than 200 lawyers and consultants in eight practice areas. 

Nikki previously co-chaired the firm’s Life Sciences and Healthcare Industry Group for six years, which is comprised of more than 450 lawyers across seventeen practice areas in the firm. 

In 2024, Nikki was a winner of Corporate Counsel’s 2024 Women, Influence & Power in Law Award for Law Firm Thought Leadership. Nikki was named a 2020 Law360 Compliance MVP, named a LMG Life Sciences Star in FDA Pharmaceutical and in FDA Medical Device from 2019 to 2023, and has been ranked nationally by Chambers USA since 2021 for Life Sciences: Regulatory Compliance and for Pharmaceuticals/Medical Products Regulatory. 

Brian Malkin

Brian Malkin has more than 30 years of FDA law and policy experience and over 20 years intellectual property law experience, including 9 years at the FDA (Commissioner’s Office and CDER) and boutique FDA and IP and international law firms, where his practice focused on innovative and generic/biosimilar pharmaceutical and biologic products. At Teva, Brian counsels on FDA regulatory law and strategy, medical affairs, labeling and safety issues, and pre-and post-approval development challenges.

FDA Watch subscribers are invited to register for the Annual Meeting of NYSBA’s Food, Drug and Cosmetic Law Section held in the NYC Hilton Midtown on January 16, 2025, from 8a.m. to 1 p.m.  The meeting features two panels moderated by Brian Malkin from this episode of the podcast. All registered lawyers and paralegals may register—call 518-463-3200.