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
Drugs
FDA has cited Chinese active pharmaceutical ingredient manufacturer Hubei JXBio Pharmaceutical Co for multiple deficiencies in its handling of deviations and out-of-specification results following a March 2025 inspection, according to a just-posted FDA Form 483. The inspection of Hubei JXBio identified shortcomings in the company’s documentation,
Drugs
FDA is seeking public input on whether to revise a longstanding series of manufacturing guidance documents that govern how drugmakers manage postapproval changes to their products. Comments are being sought on updating the agency’s Scale-Up and Postapproval Changes (SUPAC) guidances, which outline a risk-based framework for evaluating
Drugs
FDA has posted a new draft guidance entitled “New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers.” The document is intended to assist applicants requesting new clinical investigation exclusivity (“3-year exclusivity”) for a new drug application (NDA) or NDA supplement and provides other information about
Drugs
FDA has issued 30 Warning Letters to telehealth companies for making false or misleading claims about compounded GLP-1 medications on their Web sites. “Compounded drugs can be important for overcoming shortages or meeting unique patient needs—but compounders should not try to compound drugs in a way that circumvents
Drugs
FDA has published the International Council for Harmonization’s M14 guidance, General Principles on Planning, Designing, Analyzing, and Reporting of Non-interventional Studies that Utilize Real-World Data for Safety Assessments of Medicines. The document covers general principles for planning, designing, analyzing, and reporting non-interventional studies that use fit-