Drugs
FDA has published for public comment an International Council for Harmonization draft guideline, General Considerations for Patient Preference Studies E22, with general considerations about the use, design, conduct, analysis, and submission of patient preference studies (PPS) aimed at informing drug development, regulatory submission and evaluation, drug approvals, and maintenance of
FDA Policy/General
Sangamo Therapeutics has begun a rolling BLA submission seeking accelerated approval of its experimental Fabry disease gene therapy, following results from a registrational study that the agency has agreed can serve as the primary basis for approval. The company says that data from its Phase 1/2 STAAR study support
Drugs
Bayer is reporting that its investigational oral anticoagulant asundexian reduced the risk of recurrent ischemic stroke by 26% in patients who had recently experienced a non-cardioembolic ischemic stroke or a high-risk transient ischemic attack, without increasing major bleeding. The findings are from the company’s just-reported pivotal
Drugs
At the 1/6 meeting of the PDUFA 8 CMC Subgroup, industry representatives explained their counterproposal to FDA’s facility lifecycle proposal. The meeting minutes indicate that industry proposed a timeline for communications associated with the form FDA-483 that is issued after a pre-approval inspection. The minutes say
Drugs
Telehealth firm Hims and Hers Health is offering compounded GLP-1 weight loss pills for $49 per month for new customers and $99 per month thereafter as part of a five-month plan, some $100 per month under the lowest price charged by innovator firm Novo Nordisk for its Wegovy
Devices
Johnson & Johnson MedTech has recalled (Class 1) multiple versions of its Cerepak Detachable Coil System, which is manufactured by subsidiary Cerenovus, for treating intracranial aneurysms and other neurovascular conditions. An FDA recall notice says the devices are being removed from hospitals and other points of use after the manufacturer
Drugs
FDA has updated the safety labeling for the widely used chemotherapy drugs capecitabine (Genentech’s Xeloda) and fluorouracil (multiple manufacturers) to strengthen warnings about the risk of serious and potentially fatal toxicities in patients with dihydropyrimidine dehydrogenase (DPD) deficiency. Capecitabine and fluorouracil are cornerstone chemotherapies used across a wide range
Devices
FDA has published a guidance, Computer Software Assurance for Production and Quality Management System Software, to supplement an earlier guidance on General Principles of Software Validation. The new document contains recommendations on computer software assurance for computers and automated data processing systems used as part of medical device production or
Devices
A 10/20-10/30/2025 FDA inspection at the Flextronics America facility in Austin, TX, found Quality System Regulation violations in the firm’s manufacturing of a continuous glucose monitor. A 1/27 Warning Letter says the specific violations were: * failure to adequately ensure that when the results of
Drugs
An 8/4-8/12/2025 FDA inspection at the Cohance Lifesciences drug manufacturing facility in Uppal Mandal, Medchal-Malkajgiri, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 1/30 Warning Letter says the specific violations were: * failure to thoroughly investigate any unexplained
Drugs
Responding to an FDA request for information on increasing access to nonprescription drugs, Pharmaceutical Research and Manufacturers of America (PhRMA) says that while it is aligned with the goal of increasing access to nonprescription drugs, Rx to over-the-counter (OTC) switch decisions “must remain rooted in scientific analysis of
Devices
Three Hogan Lovells attorneys say FDA’s new medical device inspection protocol that aligns with the new Quality Management System Regulation will require device manufacturers to prepare for a significant operational and cultural transformation for undergoing, addressing, and responding to inspections and remote regulatory assessments. Writing in an online post,
Devices
FDA has classified Abbott Diabetes Care’s recall of certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus continuous glucose monitoring sensors as a Class I recall, the agency’s most serious designation, warning that continued use could cause serious injury or death. The recall involves specific lots of the
Drugs
Senior officials in the Trump administration intervened last year to prevent FDA from placing a promising new psychedelic treatment for severe depression on a priority fast-track review list, according to multiple media reports. The treatment, developed by Compass Pathways and derived from psilocybin — the psychedelic compound found in so-
Drugs
President Trump has signed a government spending bill that officially reinstates FDA’s Rare Pediatric Disease Priority Review Voucher (PRV) program, reviving a key incentive for rare childhood disease drug development that had lapsed more than a year ago. The provision, part of the Consolidated Appropriations Act of 2026 signed
Drugs
Amgen is pushing back against an FDA request asking it to voluntarily withdraw its vasculitis drug Tavneos (avacopan) from the U.S. market due to concerns related to clinical trial adjudication and liver safety. In an Amgen notice to healthcare providers, the company says it has no plans to withdraw
Biologics
AstraZeneca and Daiichi Sankyo’s antibody–drug conjugate Datroway (datopotamab deruxtecan) has been granted an FDA priority review as a potential first-line treatment for patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for immunotherapy. Triple-negative breast cancer accounts for about 15% of
Devices
Former CDRH branch chief for diagnostic and surgical devices Morris Waxler, who was involved in the original approval of laser eye surgery (LASIK) and later a prominent critic of the procedure, has passed away at the age of 88 in a hospital in Madison, WI. His wife, Carolyn Zahn-Waxler,
FDA Policy/General
FDA’s regulatory responsibilities expanded substantially between fiscal years 2008 and 2024, even as the agency now faces workforce reductions and organizational restructuring that could further strain its oversight capacity, according to a new report from the Government Accountability Office. The just-released GAO report examines how FDA’s authority,
Drugs
FDA has issued AstraZeneca a complete response letter declining to approve its BLA for a subcutaneous formulation of Saphnelo (anifrolumab) for treating adult patients with systemic lupus erythematosus (SLE). AstraZeneca says it has submitted the additional information requested by FDA and is continuing to work with the agency to advance
Devices
An FDA review of records submitted at the agency’s request by Unomedical Device in Reynosa, Tamaulipas, Mexico, identified Quality System Regulation and Medical Device Reporting violations in the firm’s manufacturing of infusion sets for subcutaneous insulin delivery in diabetic patients. A just-released 1/8 Warning Letter says
Devices
A 10/14-10/23/2025 FDA inspection at the Abbott Diabetes Care facility in Alameda, CA, found Quality System Regulation violations in the firm’s manufacturing of flash and continuous glucose monitoring systems. A 1/23 Warning Letter says the specific violations were: * failure to adequately establish and maintain