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Federal Register notice: FDA is reopening the comment period for its draft guidance entitled “E6(R3) Good Clinical Practice: Annex 2” to allow interested persons additional time to submit comments.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
FDA Policy/General
Federal Register notice: FDA is making available its decision to deny a request for a hearing on a recent CDER refusal to approve a Vanda supplemental NDA for Hetlioz (tasimelteon) capsules for treating insomnia characterized by difficulties with sleep initiation. The refusal was outlined in a 3/2024 complete response
FDA Policy/General
Most of FDA’s drug inspection-based Warning Letters issued in fiscal year 2024 went to domestic firms, although the percentage of international firms being inspected ticked upward, according to Eliquent Life Sciences’ (formerly consulting firm Greenleaf Health) officials Liz Oestreich, Kalah Auchincloss, and Erin Hartmann. Writing in an online
FDA Policy/General
FDA commissioner-nominee Marty Makary has pledged to do his own “independent assessment on personnel” before recommending if any additional staff cuts are warranted at the agency. During his 3/6 Senate confirmation hearing before the Health Education Labor & Pensions (HELP) Committee, Makary made the promise to appease criticism
FDA Policy/General
The Trump Administration is reversing an Elon Musk decision (see earlier story) to terminate the lease of a 52,000 square foot major FDA laboratory in St. Louis, MO. Despite its continued listing on Musk’s Department of Government Efficiency (DOGE) “Wall of Receipts” as saving $2.5 million annually
FDA Policy/General
Ohio State University researchers say generic drugs made in India are linked to a significantly higher number of adverse events, including hospitalizations and deaths, than their counterparts that are made in the U.S. SciTechDaily reports online that the study was published in the journal Production and Operations Management. The
FDA Policy/General
FDA has placed a clinical hold on BioNTech’s Phase 1/2a dose escalation clinical trial (NCT06069544) evaluating the safety, tolerability, immunogenicity and efficacy of an investigational RNA-based vaccine (BNT165e) for preventing P. falciparum malaria in healthy malaria-naive adults. The company says the trial is being paused while
FDA Policy/General
In a 2/24 ethics letter submitted to the HHS associate general counsel for ethics, FDA commissioner nominee Martin Makary says he will resign his position at Johns Hopkins University upon his confirmation as commissioner and will divest his many equity and non-equity holdings. The letter says that when
FDA Policy/General
A 9/17-9/20/2024 FDA inspection at the Chem-Tech drug manufacturing facility in Pleasantville, IA, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 2/11 Warning Letter says the specific violations were: * failure to thoroughly investigate any unexplained discrepancy
FDA Policy/General
FDA has accepted for priority review a Capricor Therapeutics BLA for deramiocel, a cell therapy for treating patients diagnosed with Duchenne muscular dystrophy (DMD) cardiomyopathy. The agency has set a user fee review action target date of 8/31. The submission is based on existing cardiac data from the company’
FDA Policy/General
“Dozens” of annual reports sent by drug companies to the Securities and Exchange Commission (SEC) warn of the impact of FDA staff and resource cuts, according to an online Wired post. The post says that Xenon Pharmaceuticals told the SEC the Trump administration “has enacted several executive actions that could
FDA Policy/General
CDER's Office of Prescription Drug Promotion (OPDP) has cited Edenbridge Pharmaceuticals over promotional materials used at a medical meeting exhibit booth because they made “false or misleading claims and representations about the risks and benefits of Hemady,” according to a just-posted untitled letter. “These violations are concerning
FDA Policy/General
Protagonist Therapeutics and Takeda are announcing “positive topline results” for the Phase 3 VERIFY study, in which phlebotomy-dependent patients with polycythemia vera (PV) received rusfertide or placebo as an add-on to standard of care treatment. The study met its primary endpoint and all four key secondary endpoints, according
FDA Policy/General
With a potential government shutdown looming in two weeks, FDA’s ability to use its user fee carryover balances to fund product review operations during a shutdown may be unlikely because the agency is further along in the fiscal year and those balances are likely depleted, according to BrownStein lawyers