M. Nielsen Hobbs

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

Pink Sheet Podcast: Understanding The US FDA Reduction-In-Force And Its Long-Term Impact Pink Sheet reporter and editors discuss how the massive layoffs will reshape the FDA and its impact on the drug and biologics industries. What are the long-term impacts of the RIF on the FDA? • Source: Citeline/Shutterstock

1 month ago | insights.citeline.com | Derrick Gingery |Sarah Karlin-Smith |M. Nielsen Hobbs

Pink Sheet Podcast: US FDA Productivity Complaints Emerge, Internal Return To Office HeadachesPink Sheet reporter and editors discuss industry worries about delays in the FDA’s work since the Trump Administration took office, as well as the chaotic return of staff to a White Oak headquarters that cannot handle them. How will the return-to-office mandate impact FDA productivity? • Source: Citeline/Shutterstock

1 month 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

1 month 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

1 month 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.