FDA Policy/General
FDA and HHS have launched a public Request for Information to “identify and eliminate outdated or unnecessary regulations.” An FDA statement says the initiative is part of a broader federal effort to reduce regulatory burdens and increase transparency in line with President Donald J. Trump’s Executive Order on “Unleashing
FDA Policy/General
FDA is preparing to begin negotiation sessions in September to reauthorize the Prescription Drug User Fee Act (PDUFA), which expires 9/2027. A new notice is seeking public stakeholders — patient and consumer advocacy groups, healthcare professionals, and scientific and academic experts — to participate in periodic consultation meetings. The agency is
FDA Policy/General
Speakers at the recent DTC National conference on direct-to-consumer advertising suggested that despite calls for a ban on consumer advertising by HHS secretary Robert F. Kennedy, Jr., the odds of such a ban being implemented remain low. Representing the Healthcare Advertising Coalition, Jim Potter discussed the legal and
FDA Policy/General
Former FDA commissioners Scott Gottlieb and Mark McClellan say a plan circulated by the Department of Health and Human Services to restructure FDA by consolidating the product Centers that review drugs, biologics, animal health, medical devices, and tobacco into a single regulatory office would face many challenges. Writing in an
FDA Policy/General
FDA commissioner Michael Makary says the agency will expand the use of artificial intelligence (AI)-assisted scientific reviews across all Centers by 6/30. In a statement, he says the rollout follows the successful completion of a new generative AI pilot for scientific reviewers. “I was blown away by the
FDA Policy/General
The recent FDA reductions in force involving leadership, inspection administration, and travel logistical planners has been incredibly disruptive to the inspection cadre, but they do not rise to the level of disruption that was caused by the Covid-19 pandemic, former CDER Office of Compliance director (retired 2022) and now
FDA Policy/General
Theriva Biologics says its VCN-01 (zabilugene almadenorepvec) hit its endpoints in the VIRAGE Phase 2b trial using VCN-01 and standard of care (gemcitabine/nab-paclitaxel) as first-line therapy for patients with metastatic pancreatic ductal adenocarcinoma. A company statement says 48 patients treated with at least one dose
FDA Policy/General
Sen. Eric Schmitt (R-MO) has introduced legislation to create new inspectors general for FDA, the Centers for Disease Control and Prevention, and the National Institutes of Health. In a statement, Schmitt says the Improving National Safety, Public Health, Ethics, and Clinical Trials (INSPECT) Act is needed because “Americans’ trust
FDA Policy/General
FDA associate commissioner for inspections and investigations Michael Rogers, who has worked for the agency for more than 30 years, is retiring effective 5/14, reportedly over staff frustration with commissioner Martin Makary. “I have decided to retire,” Rogers told CBS News. “It was my decision, but it was time
FDA Policy/General
FDA has tapped former Booz Allen Hamilton chief technologist Jeremy Walsh to lead its artificial intelligence (AI) and information technology efforts in a newly created leadership role — Chief AI Officer. Walsh announced his appointment via LinkedIn and it was first reported by Politico. Walsh served for 14 years as chief
FDA Policy/General
FDA has approved Teva Pharmaceuticals and Alvotech’s Selarsdi (ustekinumab-aekn) injection as an interchangeable biosimilar to Janssen’s reference biologic Stelara (ustekinumab) for treating psoriatic arthritis and plaque psoriasis, as well as Crohn’s disease, and ulcerative colitis. Ustekinumab is a human monoclonal antibody that selectively targets the p40
FDA Policy/General
FDA has appointed University of California, San Francisco professor and vocal FDA-industry critic Vinay Prasad to serve as CBER’s new director, replacing Peter Marks, who abruptly resigned last month rather than support what Marks described as HHS secretary Robert F. Kennedy Jr.’s “misinformation and lies” (see earlier
FDA Policy/General
Drug study information in NDAs/BLAs will need to be electronically submitted, beginning 12/2026, in a certain format to assist FDA in planning its bioresearch monitoring (BIMO) inspections, according to a just-posted agency Webinar. CDER says it uses the data and information described in a recent guidance to
FDA Policy/General
FDA canceled a scheduled meeting with the National Treasury Employees Union (NTEU), which represents about 9,000 FDA employees, that was to spend five hours discussing the layoffs that hit the agency earlier this year. Union leaders say the agency did not set another date for the meeting, Reuters reports.
FDA Policy/General
FDA says it is withdrawing two recent final guidances on cell- and tissue-based products and reissuing them in draft form that makes modifications based on undisclosed comments made by stakeholders. The guidances are “Recommendations To Reduce the Risk of Transmission of Disease Agents Associated with Sepsis by Human Cells,
FDA Policy/General
FDA has begun rehiring some Freedom of Information office workers who were terminated under White House-mandated reduction-in-force cuts. The move was expected after HHS secretary Robert F. Kennedy Jr said 4/21 that the many employees would see their positions restored at FDA and other health agencies’
FDA Policy/General
FDA is working to rehire about one-third of the 60 travel support staff who were fired as part of an agency-wide reduction in force. The Associated Press reports the agency also plans to recall food scientists who were fired, but they have not yet received formal written notification
FDA Policy/General
FDA staff reductions in force appear to be hurting programs that track drug safety, according to anonymous sources who spoke with Chemical & Engineering News. A fired employee told the newsletter that “there’s a handful of employees desperately keeping the lights on.” The report says the CDER Division of
FDA Policy/General
A new poll finds that 44% of the U.S. public says that having new leaders in charge of federal public health agencies will make them trust recommendations coming from the organizations less than they used to (30% a “lot less” and 14% a “little less).” The poll was published
FDA Policy/General
Four Skadden attorneys say the 4/1 layoff of 3,500 FDA employees will likely have the greatest impact on products in development because the agency may not be able to issue as much guidance as it had previously or provide feedback and updates on applications. Writing in an online
FDA Policy/General
A “well-reasoned” recent Supreme Court opinion in a case involving FDA “is a welcome source of reassurance at a time when President Donald Trump is waging an unprecedented attack on regulatory agencies.” That’s the view of George Washington University School of Law professor Richard Pierce, writing in The
Biologics
FDA commissioner Martin Makary says there will be no agency-wide reorganization. Interviewed by Jeremy Faust for an Inside Medicine Substack post, Makary said some staff asked for a reorganization and he rejected the proposal. “We are consolidating travel office, information technology, and some other things that make sense for