FDA Policy/General
Just as the dust is barely settled from recent firings of about 1,000 FDA probationary staff and the subsequent rehiring of 200 CDRH reviewers, the Trump administration issues a memo asking agencies like FDA to “undertake preparations to initiate large-scale reductions in force (RIFs), consistent with applicable law.
FDA Policy/General
HHS has appointed Robert Fox Foster as FDA’s next chief counsel. Foster previously served in the first Trump Administration as an HHS advisor to the Assistant Secretary for Preparedness and Response (4/2020 to 1/2021). He then moved to Capitol Hill to serve as a senior attorney on
FDA Policy/General
The White House says a list of more than 20 “prohibited words” that has been circulating at FDA may have misinterpreted the Trump administration’s gender ideology Executive Order. Reuters reports it was told by two sources familiar with the matter who requested anonymity out of fear of professional repercussions
FDA Policy/General
Sens. Dick Durbin (D-IL) and Roger Marshall (R-KS) have introduced the Protecting Patients from Deceptive Drug Ads Act to improve FDA oversights of drug ads by social media influencers and telehealth companies. A statement issued by Durbin says there generally is a gap in FDA oversight when it
FDA Policy/General
Advamed president Scott Whitaker has written HHS to urge a reversal of staff cuts at CDRH to avoid a negative impact on patient care. “Device review times were already too long, though they were improving as the result of our latest user-fee agreement,” Whitaker said in a Linkedin post
FDA Policy/General
In a guest Med Device Online column, ERA Sciences executive director Eva Kelly lists and analyzes FDA’s top five citation issues for data quality in 2024. The issues were: * governance and standard operating procedure weaknesses; * validation deficiencies; * system inventory gaps; * missing records or data missing key ALCOA++ (attributable, legible,
FDA Policy/General
The Trump Administration fired hundreds of FDA probationary employees over the weekend as part of its efforts to shrink government spending. Media reports indicated that a substantial number of terminations were at CDRH, and it appears that cuts to staff were widespread and affected those conducting drug inspections and working
FDA Policy/General
[Obituary by Jim Dickinson, his friend] Back in the so-called Good Old Days before user fees leveled the playing field, FDA bureaucrats ruled the regulatory roost, secure in their Chevron USA v NRDC power to assert their will until one quiet-spoken lawyer defeated them in a little-noticed
FDA Policy/General
Two Web pages on draft guidances that FDA was ordered by a federal judge to restore earlier this week (see story) are back online, but they now include a Trump administration statement that disparages and condemns gender ideology. One draft guidance is intended to increase enrollment of females in clinical
FDA Policy/General
The U.S. Senate has confirmed vaccine skeptic Robert F. Kennedy Jr. to serve as HHS secretary. The 52-48 confirmation vote closely mirrored party lines, with only one Republican defection — Mitch McConnell (R-KY), who is retiring at the end of his term next year and has often been
FDA Policy/General
DC federal judge John Bates has issued a temporary restraining order (TRO) requiring FDA and the Centers for Disease Control and Prevention (CDC) to restore Web pages they removed to comply with President Donald Trump’s executive order on gender ideology that mandated the recognition of only male and female
FDA Policy/General
FDA has released a final guidance entitled “Institutional Review Board (IRB) Written Procedures” that is intended to harmonize FDA and HHS’ Office for Human Research Protections (OHRP) regulatory requirements on clinical trial human subject protections. The document says FDA and OHRP believe that when institutions and IRBs develop and follow
FDA Policy/General
A group of 24 Senate Democrats have written HHS acting secretary Dorothy Fink asking the Department to end the ongoing and unprecedented freeze on all external communications and funding at government health agencies, including FDA. “We write to express our deep concern over the Administration’s recent decision to freeze
FDA Policy/General
The White House is preparing an executive order to fire thousands of HHS employees, according to a Reuters report that says the story was broken by the Wall Street Journal based on anonymous sources. According to the Journal, Reuters says, the order could come as soon as next week and
FDA Policy/General
Doctors for America, a health justice organization representing 27,000 doctors and medical students nationwide, is suing FDA, CDC, HHS, and the federal Office of Personnel Management over the removal of a broad range of health-related data and other information used by health professionals and researchers from publicly accessible
FDA Policy/General
Federal Register notice: FDA is revising the effective dates on two recent final guidances entitled “Recommendations To Reduce the Risk of Transmission of Disease Agents Associated with Sepsis by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)” and “Recommendations To Reduce the Risk of Transmission of Mycobacterium
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection revision entitled “Labeling Requirements for Prescription Drugs.” The collection supports the statutory and regulatory requirements that govern the labeling of prescription drugs. The collection is being revised to include burden associated new medical gas labeling requirements established by a
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection revision entitled “Biosimilars User Fee Program.” The document supports the agency’s biosimilar review and user fee program that allows an abbreviated approval pathway for biological products shown to be biosimilar to or interchangeable with an FDA-licensed reference
FDA Policy/General
[Analysis by David McFarland] Senate Health Education Labor & Pensions Committee chair Bill Cassidy (R-LA) is having trouble reconciling HHS secretary-nominee Robert F. Kennedy Jr.’s past positions on vaccine skepticism with his current stance to make America the healthiest country in the world. During his concluding remarks
FDA Policy/General
The January Kaiser Family Foundation Tracking Poll on Health Information and Trust documents a continuing decline in public trust in government health agencies that began during the Covid-19 pandemic. Trust in FDA has fallen from 65% in 6/2023 to 53% in 1/2025, the poll shows. The Centers
FDA Policy/General
Robert F. Kennedy Jr. faced heated criticism and questioning from Democrat senators for his stances on vaccines, abortion rights, and conflicts of interest during a 1/29 Finance Committee confirmation hearing for HHS secretary. However, Republican resistance was all but absent at the hearing, which may foretell Senate passage if
FDA Policy/General
On the eve (1/28) of Robert F. Kennedy Jr.’s confirmation hearing on his nomination to lead the Department of Health and Human Services (HHS), opposition to his potential leadership continued to grow louder and included a scathing letter to U.S. senators from cousin Caroline Kennedy (president John