Biologics
CBER director Vinay Prasad will step down at the end of April, according to HHS. His departure comes on the heels of several recent controversial decisions at the Center and news of an internal investigation into complaints from staff. HHS did not provide additional details about the reason for his
Drugs
An FDA official discussing an ongoing dispute this week with UniQure over its gene therapy for Huntington’s disease (see story) also raised concerns with outside experts who sit on agency advisory committees. The official, who spoke on condition of anonymity, criticized the advisory committees, suggesting some outside experts “do
Devices
FDA says an expanded recall by Medline Industries involving certain reprocessed electrophysiology and ultrasound catheters has been classified as Class 1, warning that the devices could cause serious injury or death if used. The recall affects several catheters distributed through Medline’s ReNewal reprocessing program, including models originally manufactured by
FDA Policy/General
FDA has issued a draft guidance outlining how drug manufacturers should respond to inspection findings documented in an FDA Form 483, urging companies to submit detailed remediation plans quickly and take a more systematic approach to correcting quality problems. The document describes best practices for responding to inspectional observations identified
FDA Policy/General
After a year at the agency, FDA deputy commissioner for operations and chief operating officer Barclay Butler has announced his retirement in the coming months, according to an internal email. FDA commissioner Marty Makary has named Butler’s deputy, Melanie Keller, to assume his duties effective 4/6. Before joining
Devices
Ropes & Gray attorneys Joshua Oyster and Austin Laroche review in a WestLaw Today article FDA’s new inspection approach for medical device manufacturers under the Quality Management System Regulation and discuss key changes from prior inspection methods. The attorneys note that the updated regulatory framework signals a shift toward
Drugs
Acting on behalf of an “interested client,” a Buchanan petition asks FDA to take immediate administrative and enforcement action against 503B outsourcing facilities distributing adulterated and misbranded ophthalmic Bevacizumab products. The petition asks FDA specifically to: * issue an order and/or formal guidance clarifying that compounded ophthalmic bevacizumab products do
Drugs
Senate Select Committee on Aging chairman Rick Scott (R-FL) and ranking member Kirsten Gillibrand (D-NY) have contacted CVS, Walgreens, and Walmart with additional questions about their efforts to safeguard the integrity of the U.S. drug supply chain. The letter commends the three companies for their “proactive efforts
Biologics
A senior FDA official sharply criticized UniQure’s investigational gene therapy for Huntington's disease, calling it a “failed product” during a 3/5 conference call with reporters and intensifying doubts about the treatment’s regulatory prospects, according to Reuters. The remarks came days after the company said FDA
Drugs
FDA has approved Janssen Biotech’s Tecvayli (teclistamab) in combination with Darzalex Faspro (daratumumab hyaluronidase-fihj) for adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent. The approval also converts teclistamab’s previous
Devices
The former chief regulatory officer at medical technology company ExThera Medical Corp. has been charged with concealing serious adverse events — including two patient deaths — from FDA in connection with a blood filtration device used on cancer patients treated outside the U.S., federal prosecutors said 3/5. The U.S.
Drugs
FDA has granted Hemab Therapeutics a breakthrough therapy designation for sutacimig, an experimental therapy being developed to prevent bleeding episodes in patients with Glanzmann thrombasthenia. Hemab said sutacimig could become the first prophylactic therapy specifically designed to prevent bleeding in people with Glanzmann thrombasthenia, a rare inherited platelet disorder that
Devices
A petition submitted by Harmed Americans for Reform in Medical Device Safety (HARM) calls on FDA to investigate Mayo Clinic's promotion and use of robotic nipple-sparing mastectomy using a da Vinci surgical system. The petition says Mayo is using the robotic system outside the ongoing IDE. It
FDA Policy/General
FDA has placed a partial clinical hold on a mid-stage U.S. trial of PepGen Inc.’s experimental therapy for myotonic dystrophy Type 1. The action affects the Phase 2 FREEDOM2-DM1 multiple ascending dose study of PGN-EDODM1 in patients with myotonic dystrophy Type 1. According to PepGen,
Drugs
Rep. Jake Auchincloss (D-MA) is escalating his criticism of FDA’s new voucher program that offers select drugmakers sharply shortened review timelines, arguing the program undermines scientific standards and the agency’s credibility. In an interview with U.S. News & World Report, Auchincloss, a member of the House
Drugs
FDA is reviewing a petition to add sweeping new Warnings to commonly prescribed antidepressants, a process now complicated by the involvement of the agency’s top drug official, who is attempting to hire the physician behind the request. Acting CDER director Tracy Beth Hoeg is reportedly working to recruit Adam
FDA Policy/General
FDA has finalized a sweeping overhaul of the National Drug Code system, adopting a standardized 12-digit format for the identifier used to uniquely distinguish prescription and over-the-counter drugs marketed in the U.S. Under a new final rule, the agency will replace the current 10-digit National
Drugs
FDA has just posted the form FDA-483 with six observations from a 5/25-6/2/2023 inspection at the Fujian Genohope Biotech sterile drug manufacturing facility in Putian, Fujian, China. The specific inspection observations were: * failure to follow written procedures for the receipt, identification, storage, handling, sampling, testing,
Drugs
FDA has denied an 8/17/2025 petition filed by Age Reversal Unity seeking a regulatory framework for conducting expedited clinical trials of aging-related therapeutics within a nine-month timeframe. The agency’s denial letter says, “FDA does believe that issuing such a one-size-fits-all framework is
Devices
A 7/21-8/19/2025 FDA inspection at Diasol, Inc., in Phoenix, AZ, found that the company is manufacturing unapproved disinfectants used to disinfect dialysate delivery systems and water purification systems used in hemodialysis to treat patients with renal failures or toxemic conditions. A just-released 1/29 Warning
Drugs
FDA has denied a 6/12/2025 BioMarin petition asking for agency actions relating to C-type natriuretic peptide analogs. The denial letter says BioMarin asked that FDA: * refrain from approving any C-type natriuretic peptide (CNP) analog as a treatment for achondroplasia in any pediatric patients until 11/19/
Drugs
FDA has granted Vanda Pharmaceuticals a long-sought formal evidentiary public hearing to review the agency’s proposal to refuse approval of a supplemental NDA for Hetlioz (tasimelteon) and its use for treating jet lag disorder. A 3/2 letter from FDA’s Office of the Commissioner confirmed the hearing