M. Nielsen Hobbs

2 months ago | insights.citeline.com | Derrick Gingery |Sarah Karlin-Smith |M. Nielsen Hobbs

Pink Sheet Podcast: Buyouts, Departures and Other US FDA Chaos Pink Sheet reporter and editors discuss the early retirement and buyout offers to FDA employees and significant agency departures in the Center for Biologics Evaluation and Research and chief counsel’s office as a new commissioner moved closer to confirmation. How long before the FDA staffing reductions begin to impact its services? • Source: Citeline/Shutterstock

2 months ago | insights.citeline.com | Derrick Gingery |Sarah Karlin-Smith |Sue Sutter |M. Nielsen Hobbs

Pink Sheet Podcast: What We Learned From US FDA Commissioner Nominee Makary’s Confirmation Hearing Pink Sheet reporters and editors discuss FDA Commissioner nominee Martin Makary answers to senators’ questions and the potential impact of his views on the agency. The Senate Health, Education, Labor and Pensions Committee will vote to send Makary's nomination for FDA Commissioner to the full chamber on 13 March. • Source: Citeline/Shutterstock

2 months ago | insights.citeline.com | Derrick Gingery |Sarah Karlin-Smith |M. Nielsen Hobbs |Elizabeth Orr

Pink Sheet Podcast: Laid Off US FDA Staff Called Back, Vaccine Adcomm Cancelled, Lilly’s Manufacturing PushReporter and editors from the Pink Sheet and Medtech Insight discuss the impact of the FDA’s decision to call back many of the employees it laid off, the decision to cancel an upcoming FDA advisory committee meeting on flu vaccines, and Eli Lilly’s plans to increase domestic manufacturing. The VRBPAC meeting cancellation generated a lot of speculation about the FDA's reason for the move.

2 months ago | insights.citeline.com | Derrick Gingery |Sarah Karlin-Smith |Sue Sutter |M. Nielsen Hobbs

Pink Sheet Podcast: Understanding the US FDA Layoffs And Their Impact On IndustryReporter and editors from the Pink Sheet, Medtech Insight and HBW Insight consider the impact of the layoffs at the FDA on its drug, device and consumer products divisions, as well as the so-far limited public reaction from industry. Will the FDA layoffs impact application reviews and inspections? • Source: Citeline/Shutterstock

2 months ago | insights.citeline.com | Derrick Gingery |M. Nielsen Hobbs |Michael McCaughan

Pink Sheet Podcast: RFK’s First Actions, Pitch To Extend Current US FDA User Fee Agreement, More Trump ImpactsPink Sheet editors and special guest Michael McCaughan of Prevision Policy discuss Robert F. Kennedy Jr.’s first act as HHS Secretary, former FDA Commissioner Scott Gottlieb’s suggestion that industry extend the existing user fee agreement rather than negotiate a new one, and President Trump’s policies impacting FDA advisory committee schedules and staffing.