FDA Watch

Wayne chats with Brian Sylvester, Partner in Morrison Foerster's FDA and Healthcare Regulatory and Compliance Group, and Scott Faber, Senior Vice President of Government Affairs for the Environmental Working Group. You'll hear their thoughts on the recent appointment of former Deputy Commissioner of Human Foods Kyle Diamantas to Acting Head of FDA after the resignation of former Commissioner Dr. Marty Makary; the direction and drivers of food regulation; the phase-out of synthetic food dyes amid growing state-level action; where FDA's interest in overhauling GRAS stands; the potential formal definition of "ultraprocessed" foods and potential labeling and nutrition implications; the balance between precautionary regulation and evidence-based flexibility for industry; how AI is changing the regulatory landscape amid FDA's rollout of Elsa; and much more.
In our headlines segment, Wayne highlights these major developments:

Dr. Marty Makary resigns as FDA Commissioner, Human Foods Deputy Commissioner Kyle Diamantas in as Acting Head

FDA to pilot "one-day inspectional assessments"

Pharma: FDA issues final guidance on the collection of pregnancy safety data for drugs and biologics after approval

Devices: FDA issues recall notice involving heart devices after reports of device malfunctions that could interrupt therapy delivery

Food: FDA announces results from examination on chemical contaminants in infant formula

Cosmetics: PCPC issues statement calling on administration to take more targeted approach in Section 301 investigation into excess manufacturing capacity

In our Resource Links segment, we list key documents in our four 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 [email protected].
Music by Dvir Silver from Pixabay.

Wayne chats with Paul Kim, Principal of Kendall Square Policy Strategies LLC, and Stuart Pape, Senior Partner and Food and Drug Chair at Polsinelli. Together, they discuss the resignation of Dr. Marty Makary as FDA Commissioner, the installment of former Deputy Commissioner of Human Foods Kyle Diamantas as Acting Head of the agency, qualifications of FDA Commissioner, potential timing of a new official Commissioner, and much more.
This episode and all bonus episodes do not include the usual Headlines and Resources Links segments.
Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at [email protected]. 
Music by Dvir Silver from Pixabay.

Wayne chats with Mark DuVal, CEO of DuVal & Associate; Bryan Feldhaus, President of DuVal & Associates; and Chris Lyle, Vice President of Evidence Strategy at DuVal & Associates. You'll hear their thoughts on what's happening right now at FDA and in the medical device industry; whether companies should engage FDA early in the pre-submission process or make their case in the actual submission; common breakdowns in the submission process; the importance of real-world evidence and where companies can still fall short; holding FDA to a consistent standard after initial feedback; and much more.
In our headlines segment, Wayne highlights these major developments:

Pharma: FDA reports progress after first year of roadmap to reduce animal testing in drug development 

Devices: CDRH issues letter to combination product manufacturers with information on potential nitrosamine impurities 

Food: FDA issues warning letters to food companies following serious violations 

Cosmetics: FDA releases Grand Rounds presentation recording featuring experts from Office of Cosmetics and Colors
In our Resource Links segment, we list key documents in our four 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 [email protected]. 

Music by Dvir Silver from Pixabay.

Wayne chats with Geoffrey Levitt, Head of Global Regulatory Law at argenx, and Frank Sasinowski, Director at Hyman, Phelps & McNamara. You'll hear their thoughts on the recently introduced plausible mechanism framework for individualized therapies in ultra-rare diseases; where FDA is making meaningful progress for rare-disease sponsors and where gaps persist; the agency's willingness to exercise regulatory flexibility in rare diseases; recent experiences in dealing with FDA on orphan drugs; how the agency has fared in translating concepts such as historical data, real-world evidence, and patient engagement into review decisions; and much more.
In our headlines segment, Wayne highlights these major developments: 

Pharma: FDA-backed proposals aim to entice pharma companies to test and produce drugs domestically 

Devices: FDA launches READI-Home Innovation Challenge 

Food: FDA seeking public input on potential market name change for 18 species of rockfish 

Cosmetics: Processors must complete first biennial FDA facility registration renewals by July 1, as required under MoCRA
In our Resource Links segment, we list key documents in our four core areas. To view these links, subscribe, or find out more information about our podcast, visit FDAWatch.net.

Order the Food & Drug Law Institute's A Practical Guide to FDA's Food and Drug Law and Regulation, Eighth Edition.

Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at [email protected]. 

Music by Dvir Silver from Pixabay.

In the third part of our series in collaboration with Skadden, Wayne chats with Rachel Turow, Head of Skadden's FDA Regulatory Practice; Milli Hansen, Partner in Skadden's Mass Torts, Insurance and Consumer Litigation Group; Daniel Luks, Partner in Skadden's Mergers & Acquisitions Practice; and Douglas Stearn, Principal at Canal Row Advisors. Together, they discuss the latest developments in food regulation at FDA and at the state level; how companies may want to prepare for potential FDA and state enforcement actions and policy shifts in the coming year; how the regulatory environment impacts litigation; how regulatory uncertainty and litigation affect M&A deals; how companies can navigate the evolving food environment; and much more.
This episode and the rest of our series do not include the usual Headlines and Resources Links segments.
To 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 [email protected]. 
Music by Dvir Silver from Pixabay.