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
FDA Policy/General
Reps. Greg Murphy (R-NC), Angie Craig (D-MN), Nick Begich (R-AK), and Hillary Scholten (D-MI) have introduced the No Handouts for Drug Advertisements Act, a bill that would prohibit tax deductions for the annual $6 billion in expenses related to direct-to-consumer (DTC) advertising of prescription
FDA Policy/General
FDA has given BlackfinBio the green light to conduct a Phase 1/2 clinical trial of its novel adeno-associated virus gene therapy, BFB-101, in children with hereditary spastic paraplegia, Type 47 (SPG47). Previously, the agency awarded the company an orphan drug designation and rare pediatric disease designation for
FDA Policy/General
HHS secretary Robert F. Kennedy Jr. earlier this week vowed to restore FDA’s and other health agencies’ Freedom of Information Act (FOIA) offices that were gutted earlier this month under White House-mandated staff cuts. The removal of FOIA offices appeared to go against previous Kennedy promises of “radical
FDA Policy/General
FDA says its Electronic Submission Gateway Next Generation (ESG NextGen) went live on 4/14 and is ready to receive submissions. The previous ESG has been retired and is no longer available for submissions, a notice says. The notice says ESG NextGen is the agency’s modernized platform for securely
FDA Policy/General
Federal Register notice: FDA is seeking a limited number of drug manufacturing establishments to participate in the second year of its voluntary Quality Management Maturity Prototype Assessment Protocol Evaluation Program and its use of a refined prototype assessment protocol to evaluate quality management maturity (QMM). The voluntary program was developed
FDA Policy/General
FDA Matters founder Steven Grossman says enough has changed in the Trump administration since Martin Makary accepted the nomination to be FDA commissioner in 11/2024 that he is facing a situation in which the agency’s integrity and decision-making are at risk. Writing in his organization’s blog,
FDA Policy/General
FDA Office of Prescription Drug Promotion (OPDP) director Catherine Gray and deputy director Mark Askine have resigned after losing most their staff to Trump Administration reductions in force earlier this month, according to Politico’s AgencyIQ. HHS secretary Robert F. Kennedy Jr. , who is not a fan of direct-to-
FDA Policy/General
The Democratic Lieutenant Governors Association has written president Donald Trump urging him to support and safeguard the integrity of key federal science agencies like FDA, NIH and the CDC, among others, and asked that he promote evidence-based policymaking that strengthens public trust and protects America’s health and prosperity.
FDA Policy/General
The 9/18-9/19/2024 Global Summit on Regulatory Science was hosted by FDA with the theme “Is Regulatory Science Ready for Artificial Intelligence?” A report from the conference, published in the open-source NPJ Digital Medicine, includes 10 key principles for regulating artificial intelligence (AI) described by former
FDA Policy/General
Three CDER and Digital Health Center of Excellence staffers say advancing the use of digital health technologies (DHTs) is a priority for FDA. “We recommend engaging early with FDA when planning to integrate DHTs into a clinical investigation to design a trial that will provide meaningful results,” the three write
FDA Policy/General
FDA commissioner Marty Makary says the agency will be rolling out soon a new drug approval pathway for rare diseases and incurable conditions. In a 4/17 interview on the Megyn Kelly Show, Makary said the agency will be approving drugs based on a “plausible mechanism and on sort of
FDA Policy/General
An HHS leaked budget document circulating in Washington projects a 17% cut in FDA budget authority (BA) (non-user fee) expenditures in FY 2026 from the FY 2023 final consolidated appropriations act, according to an FDA Matters post by Steven Grossman. The post notes that the numbers are subject to
FDA Policy/General
FDA commissioner Marty Makary is announcing a new policy directive that limits those employed at regulated (e.g., pharmaceutical and medical device) companies from serving as official members on agency advisory committees. “As part of this effort, the agency will prioritize and elevate the role of patients and caregivers, strengthening