Inside FDA Pharma Policy Development – FDA Watch
Wayne chats with Rumi Young, Director of Regulatory Policy at Novo Nordisk, and Jamie Gamerman, Head of Regulatory Policy at UCB. You’ll hear their thoughts on how FDA policy is developed and is evolving; how previous PDUFAs have changed the agency’s policy agenda and how those commitments translate into guidance development; the most important scientific or technical inflection points driving FDA policy right now; what drives the development of new agency frameworks or programs; how companies internalize new FDA policies where disconnects may exist; FDA’s efforts to balance scientific integrity with regulatory flexibility in policy development for issues such as rare diseases; and much more.
Headlines
Pharma: FDA awards two more vouchers under Commissioner’s National Priority Voucher pilot program
Pharma and Devices: FDA updates approach to incorporating RWE into drug and medical device application reviews
Food: Consumer advocate coalition urges top health officials to take action to protect infant formula safety amid ongoing Clostridium botulinum outbreak
Cosmetics: FDA finds data insufficient to determine safety of most PFAS in cosmetics
Resource Links
Pharma: FDA‘s third edition of Accelerating Rare Disease Cures Program Annual Report
Devices: FDA RFI for input on new contracting approach
Food: Politico Q&A with FDA Deputy Commissioner for Human Foods Kyle Diamantas
Cosmetics: FDA draft guidance on recalls of cosmetic products under MoCRA
About Our Guests
Rumi Young
Rumi Young is Director of Regulatory Policy at Novo Nordisk, driving growth and innovation through effective biopharmaceutical policies. Previously, she led Becton Dickinson’s Regulatory Policy team leading reform in diagnostics and digital health. At the FDA, she was the Assistant Director for Injection Devices, overseeing technical and regulatory review practices for combination products. Rumi’s career also includes roles in R&D at Genentech and AstraZeneca.
Jamie Gamerman
Jamie Gamerman is the Head of Regulatory Policy at UCB. Prior to UCB, she worked at the FDA for more than a decade, most recently as a Senior Policy Advisor in the Office of Medical Policy within the Center for Drug Evaluation and Research. At the FDA, Jamie was responsible for leading multidisciplinary workgroups to develop guidance documents and regulations. Jamie earned her bachelor’s degree and her law degree from the University of Maryland.
FDA Watch Podcast 