Devices
Erbe USA has recalled (Class 1) its flexible cryoprobes due to their potential to rupture during activation, which could result in severe injury or death. To date, there have been five serious injuries linked to the malfunction, FDA says. According to Erbe USA, the issue stems from insufficient adhesive applied
Drugs
A new CDER guidance recap podcast explains the newly published FDA draft guidance on the use of Bayesian methodology in clinical trials of drug and biological products. On the podcast, CDER Office of Biostatistics master mathematical statistician James Travis says the guidance is important because, as the number of proposals
Drugs
At the 2/26 PDUFA 8 reauthorization meeting, FDA said it would consider an industry counterproposal to the agency’s America First fee incentive proposal. Meeting minutes indicate that industry representatives said FDA’s proposed three-time fee differential would be “extremely punitive rather than an incentive for substantial changes
Drugs
In an FY 2025 GDUFA Science and Research Report, GDUFA Science and Research Program joint directors Iilun Murphy and Michael Kopcha say extended GDUFA-funded research on bioequivalence (BE) risk assessments and Biopharmaceutics Classification System classification supported the FY 2025 publication of over 800 product-specific guidances that aligned FDA’
FDA Policy/General
University of Southern California Price School of Public Policy associate professor Genevieve Kanter says policymakers should consider conflict of interest policies to be part of a broader strategy of building public trust by being more trustworthy as an agency. “This includes providing comprehensive scientific justification for decisions, being transparent about
Drugs
The National Association of Manufacturers (NAM) is petitioning FDA to follow the statutory and regulatory procedures governing advisory committees under regulations and the Federal Advisory Committee Act “to allow for mandatory and all other stakeholders to comment on current and upcoming regulatory policies and procedures that FDA is discussing during
Drugs
A conservative-leaning advocacy group is taking aim at FDA, arguing in a new report that the agency’s drug review process has grown more costly and restrictive — potentially slowing patient access to new therapies. In a report titled “Blocking Breakthroughs: Delays and Denials at the FDA,” the Taxpayers Protection
Drugs
Kodiak Sciences says its anti-VEGF therapy Zenkuda (tarcocimab tedromer) hit the mark in a second Phase 3 trial in diabetic retinopathy, reinforcing a dataset the company says is now ready to support a BLA. In the GLOW2 study, 62.5% of patients treated with Zenkuda achieved at least a
Drugs
Health experts say a new FDA policy framework could mark a turning point for highly individualized genetic medicines, as regulators attempt to keep pace with technologies that can now design treatments for single patients. In a commentary published in JAMA Health Forum, former FDA commissioner Scott Gottlieb and regulatory expert
Drugs
Wave Life Sciences is reporting new interim Phase 1 data Thursday indicating that a 240 mg dose of its investigational obesity therapy WVE-007 produced stronger and more consistent reductions in key fat measures than a higher 400 mg dose, raising questions about dose-response dynamics in the early-stage
Devices
A 10/20-10/30/2025 FDA inspection at Longhorn Vaccines and Diagnostics in Bethesda, MD, found multiple violations in the firm’s work as a specification developer of the PrimeStore MTM (molecular transport medium) device intended for the stabilization, transportation, and inactivation of infectious unprocessed nasal washes suspected of
Drugs
Rezolute is trying to chart a path forward for its congenital hyperinsulinism program after its Phase 3 trial of ersodetug missed the primary endpoint, with FDA now asking for a deeper dive into the data before weighing next steps. Following a Type B meeting earlier this month, the agency encouraged
Drugs
Quoin Pharmaceuticals says FDA has signaled openness to a streamlined development path for its rare disease candidate QRX003, indicating that a single Phase 3 trial could be sufficient to support approval in Netherton Syndrome. The feedback came out of a recent Type C meeting, where regulators also suggested flexibility on
Drugs
Beam Therapeutics says it will advance its base-editing therapy BEAM-302 into pivotal development to seek accelerated approval for treating Alpha-1 Antitrypsin Deficiency (AATD) after updated Phase 1/2 data showed the drug can durably raise AAT levels above the protective threshold while sharply reducing the disease-causing
Drugs
FDA has released the form FDA-483 with four observations from a 1/30-2/7/2025 inspection at the Micro Labs finished drug products manufacturing facility in Bengaluru, Karnataka, India. The specific observations were: * failure to have in writing and fully follow the responsibilities and procedures applicable to the
Drugs
FDA has approved Corcept Therapeutics’s cortisol-modulating drug Lifyorli (relacorilant) in combination with nab-paclitaxel for patients with platinum-resistant ovarian cancer. The action is backed by data from the Phase 3 ROSELLA trial, where the combo delivered a statistically significant overall survival benefit — a relatively rare outcome in
Drugs
Five Republican members of the Senate HELP Committee want FDA to take “immediate action to prevent misbranded and unapproved versions of the chemical abortion drugs mifepristone and misoprostol from being marketed in the U.S. by online retailers in violation of U.S. law.” In a statement (includes links to
Devices
Manufacturers developing weight-loss devices should carefully review FDA’s 3/2026 final guidance closely, particularly the effectiveness thresholds, adverse event grading system, and evaluation matrices that will shape pivotal study design and premarket strategy. That’s the recommendation of Hogan Lovells attorneys Kristin Duggan and Megana Sarkaran, writing in
Drugs
A 10/21-10/24/2025 FDA inspection at the Yangzhou H&R Plastic Daily Chemical Company drug manufacturing facility in Hangji, Guangling, Yangzhou, Jiangsu, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 3/18 Warning Letter says the violations were: * failure
Devices
A 10/6-10/17/2025 FDA inspection at the IsoTis OrthoBiologics facility in Irvine, CA, found Quality System Regulation violations in the firm’s manufacturing of resorbable calcium salt bone void filler devices branded under the Accell family of products. A just-released 2/24 Warning Letter says the
FDA Policy/General
The Government Accountability Office (GAO) says FDA should publicly share information on how it determines whether advisory committee members have conflicts of interest. A GAO report says the agency does not make this information available currently because it has not finalized a required guidance on the matter more than 13
Biologics
A Heartland Institute online newsletter quotes several experts with differing opinions on why CBER director Vinay Prasad is leaving FDA for a second time. The post says that during his tenure, Prasad, in his dual role as CBER director and agency chief medical and scientific officer, “raised concerns about drugs