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
FDA Policy/General
Just as the dust is barely settled from recent firings of about 1,000 FDA probationary staff and the subsequent rehiring of 200 CDRH reviewers, the Trump administration issues a memo asking agencies like FDA to “undertake preparations to initiate large-scale reductions in force (RIFs), consistent with applicable law.
FDA Policy/General
HHS has appointed Robert Fox Foster as FDA’s next chief counsel. Foster previously served in the first Trump Administration as an HHS advisor to the Assistant Secretary for Preparedness and Response (4/2020 to 1/2021). He then moved to Capitol Hill to serve as a senior attorney on
FDA Policy/General
The White House says a list of more than 20 “prohibited words” that has been circulating at FDA may have misinterpreted the Trump administration’s gender ideology Executive Order. Reuters reports it was told by two sources familiar with the matter who requested anonymity out of fear of professional repercussions
FDA Policy/General
Sens. Dick Durbin (D-IL) and Roger Marshall (R-KS) have introduced the Protecting Patients from Deceptive Drug Ads Act to improve FDA oversights of drug ads by social media influencers and telehealth companies. A statement issued by Durbin says there generally is a gap in FDA oversight when it
FDA Policy/General
Advamed president Scott Whitaker has written HHS to urge a reversal of staff cuts at CDRH to avoid a negative impact on patient care. “Device review times were already too long, though they were improving as the result of our latest user-fee agreement,” Whitaker said in a Linkedin post
FDA Policy/General
In a guest Med Device Online column, ERA Sciences executive director Eva Kelly lists and analyzes FDA’s top five citation issues for data quality in 2024. The issues were: * governance and standard operating procedure weaknesses; * validation deficiencies; * system inventory gaps; * missing records or data missing key ALCOA++ (attributable, legible,
FDA Policy/General
The Trump Administration fired hundreds of FDA probationary employees over the weekend as part of its efforts to shrink government spending. Media reports indicated that a substantial number of terminations were at CDRH, and it appears that cuts to staff were widespread and affected those conducting drug inspections and working
FDA Policy/General
[Obituary by Jim Dickinson, his friend] Back in the so-called Good Old Days before user fees leveled the playing field, FDA bureaucrats ruled the regulatory roost, secure in their Chevron USA v NRDC power to assert their will until one quiet-spoken lawyer defeated them in a little-noticed
FDA Policy/General
Two Web pages on draft guidances that FDA was ordered by a federal judge to restore earlier this week (see story) are back online, but they now include a Trump administration statement that disparages and condemns gender ideology. One draft guidance is intended to increase enrollment of females in clinical