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
FDA Policy/General
The Senate Health Education Labor and Pensions Committee voted 3/13 to advance the nomination of Marty Makary as FDA commissioner. It now heads to a Senate floor vote, which is expected to confirm the nomination. The committee voted 14-9 to advance Makary, with senators Maggie Hassan (D-NH)
FDA Policy/General
FDA reportedly has informed its staff that they will likely face parking and office space problems when they return to in-office work on 3/17. Reuters says it has seen transcripts of division meetings in which the likelihood of disruptions was discussed. The report also says that plans for
FDA Policy/General
Justice Department attorney Hilary Perkins has been selected to serve as FDA chief counsel. For the past six-plus years, Perkins worked in Justice’s Consumer Protection Branch, most recently as assistant director. Prior to joining the government, she was an associate at Jones Day for six years. Perkins has
FDA Policy/General
Federal Register notice: FDA is reopening the comment period for its draft guidance entitled “E6(R3) Good Clinical Practice: Annex 2” to allow interested persons additional time to submit comments. Electronic or written comments can now be submitted through 3/31. To view the notice, click here.
FDA Policy/General
The FDA Center for Veterinary Medicine says its review of Web sites, a brochure, and a slide deck promoting Elanco Animal Health’s Zenrelia (ilunocitinib tablets) identified false or misleading claims or representations about the drug’s safety or effectiveness. A just-released 1/28 Warning Letter says the violations,
FDA Policy/General
Two clinical research facility owners have pleaded guilty in the U.S. District Court for the Southern District of Florida to conspiracy to commit wire fraud in connection with their work on two clinical trials testing drugs designed to treat asthma. According to a Justice Department release, Angela Baquero and
FDA Policy/General
FDA has appointed former business consultant Jim Traficant as chief of staff where he will oversee the day-to-day management and lead the agency’s major initiatives. In this role, “Mr. Traficant provides strategic direction to senior leadership to advance FDA’s priorities and works closely with the leadership
FDA Policy/General
As many as 80,000 federal employees at HHS, including FDA, are being offered up to a $25,000 buyout to retire or leave their government employment as part of a new Trump Administration tactic to cut costs. The buyouts have some exclusions, such as FDA inspectors, product reviewers (paid
FDA Policy/General
FDA has granted Plus Therapeutics an orphan drug designation to Rhenium (186Re) Obisbemeda, a radiotherapy for treating leptomeningeal metastases (LM) in patients with lung cancer. The designation is based on data from the ReSPECT-LM Phase 1 single-dose trial, according to the company. It is now advancing the therapy