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.
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.
Reporter 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.
Pink 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.
Pink Sheet reporter and editors discuss what pushed a crucial Senate Finance Committee swing vote to support Robert F. Kennedy Jr. as HHS Secretary and the FDA slowly expanding its communications with the public amid the Trump Administration freeze.
Pink Sheet reporter and editors discuss Sara Brenner’s introduction as acting FDA commissioner, Robert F. Kennedy Jr.’s confirmation hearings, the Trump Administration’s plans to end telework, and postponed meetings and other issues related to the communications freeze and travel ban.
Pink Sheet reporter and editors discuss the uncertainty created by the Trump Administration freezing most communications at the Health and Human Services Department, new travel and telework bans, as well as the delay in announcing an acting FDA leader and the impact of new executive orders on the FDA and CMS.
Pink Sheet editors consider ex-FDA officials’ advice for the Trump Administration on implementing FDA reforms, comments CDER Director Patrizia Cavazzoni made before her departure from the agency about wanting to release review documents for applications that received complete response letters, and diverging trends between CDER and CBER novel application approvals.
