US FDA
US FDA Commissioner nominee Martin Makary told Senators that he plans to review the data on the abortion pill mifepristone, raising some lawmakers concerns that older safety requirements the FDA has deemed unnecessary, like in-person dispensing, may be reinstated.
Martin Makary said he would re-evaluate the topics that deserve a Vaccines and Related Biological Products Advisory Committee review, but did not commit to rescheduling the cancelled meeting on influenza vaccine strain selection.
US FDA Commissioner nominee Martin Makary’s 6 March Senate confirmation hearing should offer insight on his alignment with HHS Secretary Robert F. Kennedy Jr.'s views and willingness to insulate the FDA from an unusual level of micromanagement by the department and White House.
The Voluntary Early Retirement Authority (VERA) plan would make many FDA employees with 20 or more years of service eligible for retirement, potentially increasing senior staff departures as the agency develops more layoff plans.
FDA Commissioner nominee Martin Makary can comply with US ethics laws while weighing in on the contentious GLP-1 compounding debate, despite recently exiting a company that connects patients with compounded semaglutide and an ophthalmology compounding business.
Reporter 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.
HHS Secretary Robert F. Kennedy Jr. is nostalgic for the 1960s. Will that include pushing the agency back to the pre-user-fee-era model of defining success based on blocking unsafe drugs, rather than accelerating access to effective ones?
The Vaccines and Related Biological Products Advisory Committee meeting next month was scheduled to select strains for the 2025-2026 flu vaccine. The cancellation could mean delays in vaccine availability.
Like the layoffs, the reason for the recalls of some laid off CDER and Office of Chief Counsel staff remains unclear.
The US FDA has navigated one round of layoff notices, but more cuts could be coming. Here are three potential scenarios.
Some FDA employees who were recently laid off by the Trump Administration are being called back to work, multiple sources confirmed to the Pink Sheet.
US pharma leadership is painting its mission, particularly its goal to end Medicare price controls, as patriotic and essential to America’s global dominance over China, a move that seems designed to align with President Trump’s priorities.
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.
With timing that is purely coincidental, but supremely ironic, the US FDA approved two new vaccines on 14 February, the second day of HHS Secretary Robert F. Kennedy Jr.’s tenure on the job.
Foster, an advisor to the HHS Assistant Secretary for Preparedness and Response during the COVID-19 pandemic and counsel to the Senate HELP Committee, also served in various legal roles at small biotech companies. He replaces agency veteran Mark Raza.
The pharmaceutical industry has been quiet on Trump's early federal government overhauls that could harm the drug business, still betting he will help produce better results than Biden.
Stakeholders are waiting for the dust to settle to better understand who was laid off as part of the Trump Administration's cuts at the FDA, the reductions' impact on applications currently under review and broader drug development efforts.
Jim Jones, the head of the FDA's food programs, resigned due to widespread layoffs at the agency imposed by the Trump administration’s Department of Government Efficiency.
Experts worry new restrictions on remote work, plans to eliminate certain employees’ job protections and workforce cuts will make the FDA a less attractive employer and hurt pharma’s efforts to get innovative medicines to patients.
Biotech execs and lobbyists try to explain the Trump Administration's policy strategy and how to thrive in it.