FDA Policy/General
FDA is looking to reprioritize its planned inspections for the rest of the year due to challenges it faces after 170 administrative and management staff were cut 4/1 under HHS’s mass firings. Many routine surveillance inspections will likely fall to the wayside as the agency prioritizes “for cause”
FDA Policy/General
HHS secretary Robert F. Kennedy, Jr. promised at his confirmation hearings to enhance transparency at HHS and the health agencies it manages, but HHS-directed employee terminations that began 4/1 will most likely diminish transparency instead. “Public health agencies should be transparent,” he said before being confirmed by the
FDA Policy/General
In a move presumably to make it easier to terminate federal employees, president Trump late last week signed an executive order to remove organized union representation from the majority of government agencies, including FDA and other HHS health agencies. Government watchers are predicting that the order will vigorously be challenged
FDA Policy/General
FDA will lose about 3,500 (18%) of its 19,000 full-time employees under a just-announced HHS restructuring in response to president Trump’s Department of Government Efficiency (DOGE) Workforce Optimization Initiative executive order. This is in addition to the 1,000 agency probationary employees who were cut
FDA Policy/General
The U.S. Senate 3/25 voted 56 to 44 to confirm the nomination of Marty Makary as the next FDA commissioner. The floor vote follows the Senate Health Education Labor and Pensions (HELP) Committee’s vote 3/13 to advance the nomination. Makary will likely be sworn in sometime
FDA Policy/General
AstraZeneca says new study data on Tagrisso (osimertinib) show an “improved overall survival trend” in patients with epidermal growth factor receptor-mutated non-small cell lung cancer. Results from the Phase 3 LAURA trial demonstrated that patients on Tagrisso lived a median 58.8 months compared with 54.1 months
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) says its review of the “Efficacy Results” Web page for Taiho Oncology’s Lytgobi (futibatinib) tablets found it makes false and misleading representations about the drug’s benefits. A 3/21 Notice of Violation says the violations are particularly concerning because the
FDA Policy/General
FDA has approved an Alnylam Pharmaceuticals supplemental NDA for Amvuttra (vutrisiran), an RNAi therapeutic for treating transthyretin amyloidosis with cardiomyopathy (ATTR-CM). Vutrisiran was previously approved for treating polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR-PN) in adults. “By rapidly knocking down both mutant and wild‑type transthyretin (TTR), vutrisiran
FDA Policy/General
FDA has approved a Novartis NDA for Fabhalta (iptacopan) for treating adults with C3 glomerulopathy (C3G) to reduce proteinuria. The rare and progressive kidney disease has historically lacked targeted treatment options, and Fabhalta is the first oral inhibitor of the alternative complement pathway, which is believed to drive C3G progression,
FDA Policy/General
As the Trump Administration is eyeing the closure of 27 FDA field offices across the U.S. under Elon Musk’s Department of Government Efficiency (DOGE) cost-cutting actions (see earlier story), the U.S. Army Corps of Engineers (USACE) just announced the successful completion of a construction project at
FDA Policy/General
Former FDA principal deputy commissioner and second-in-command Namandjé Bumpus has joined the board of Recursion, which is a self-described clinical stage “Tech/Bio” company that looks to decode biology to industrialize drug discovery. Bumpus left the agency 12/31/2024, shortly before the new administration came in.
FDA Policy/General
Former 15-year FDAer Henry Miller, now an American Council on Science and Health distinguished fellow, says uncertainty rules as FDA awaits the confirmation of commissioner-designate Martin Makary. Writing in his personal Pundicity online blog, Miller says that while specific priorities for Trump 2.0 are not yet clear,
FDA Policy/General
FDA has granted PEP-Therapy an orphan drug designation for PEP-010 and its used for treating pancreatic cancer. PEP-010 is described by the company as a first-in-class bifunctional therapeutic peptide being evaluated in an ongoing Phase 1b clinical trial in combination with chemotherapy (paclitaxel or gemcitabine)
FDA Policy/General
Federal Register notice: FDA is announcing the revocation of three Emergency Use Authorizations issued to Beckman Coulter for its Access SARS-CoV-2 IgG, Access SARS-CoV-2 IgM, and Access SARS-CoV-2 IgG II Covid-19 tests. The action is based on the company’s request because the
FDA Policy/General
Federal Register notice: FDA is updating its publication “Modifications to the List of Recognized Standards, Recognition List Number: 063,” which contains modifications to the list of standards the agency recognizes for use in device premarket reviews. The publication is intended to assist manufacturers who elect to declare conformity with consensus
FDA Policy/General
An FDA drug safety notice says the agency is aware that some patients and healthcare providers may look to unapproved versions of glucagon-like peptide-1 (GLP-1) receptor agonists as an option for weight loss. “This can be risky for patients,” the notice says, “as unapproved versions do not
FDA Policy/General
FDA is rehiring over 1,000 probationary employees that were fired last month after a Maryland federal judge ordered HHS and other federal agencies to reinstate them because proper notice was not provided as required by law. While the Trump administration appeals this and another similar decision by a federal
FDA Policy/General
Several years after remote, work-from-home convenience, thousands of FDA employees returned to work 3/17 only to be met with parking congestion and slow security line clearances. Local News 4 (Washington, DC) visited FDA’s headquarters in White Oak, MD for a closer look and reported that there
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of a Sage Therapeutics NDA for Zulresso (brexanolone) solution, 100 mg/20 mL after it told the agency that the drug product was no longer marketed and requested the withdrawal. Zulresso is indicated for treating moderate-to-severe postpartum depression. FDA says that
FDA Policy/General
Federal Register notice: FDA is denying a request for a hearing submitted by Bernardo Garmendia, and is issuing an order permanently debarring him from providing services in any capacity to a person that has an approved or pending drug product application. The actions are based on Garmendia’s 6/2023
FDA Policy/General
Former Justice Department attorney Hilary Perkins, who two days ago was selected to serve as FDA chief counsel, has abruptly resigned her post. FDA released a brief statement on “X” that read: “Hilary K. Perkins has resigned from her position as chief counsel of FDA, effective immediately.” Her ouster was
FDA Policy/General
Federal Register notice: FDA is announcing that a priority review voucher was issued to SpringWorks Therapeutics for achieving a 2/11 NDA approval for Gomekli (mirdametinib) for treating adults and pediatric patients two years of age and older with neurofibromatosis Type 1 who have symptomatic plexiform neurofibromas. To view the