Drugs
CDER deputy director for regulatory programs Doug Throckmorton is retiring in early January after 27 years at the agency. While there has been speculation that some FDA employees may be seeking the exit door based on anticipated disruptions from the incoming Trump Administration (see earlier story), CDER director Patrizia Cavazzoni
Devices
After reiterating that it believes FDA lacks the authority to regulate laboratory-developed testing services, the American Clinical Laboratory Association (ACLA) submits comments on an FDA draft guidance on predetermined change control plans (PCCP) for medical devices “to ensure that PCCPs can be leveraged by laboratories to support continued rapid
FDA Policy/General
Federal Register notice: FDA is revoking the Emergency Use Authorizations issued to Cue Health for the Cue Covid–19 Test, and Cue Covid–19 Home/OTC Test after the company requested the action because the tests are no longer being made and distributed. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is making available additional draft and revised draft product-specific guidances for generic drug sponsors. The documents provide product-specific recommendations on, among other things, the design of bioequivalence studies to support ANDA submissions. To view the notice, click here.
Drugs
FDA has used the Oncology Center of Excellence’s Project Renewal to approve labeling changes for Sandoz’ fludarabine phosphate cancer drug injection. An agency announcement says this is the third drug to receive a Project Renewal labeling update. Project Renewal is aimed at updating labeling information for certain older oncology
Devices
FDA has cleared an Ultromics 510(k) for the EchoGo Amyloidosis, an artificial intelligence-based echocardiography device to assist with early detection of cardiac amyloidosis. The company says this is the first device to reach the market under CDRH’s Total Product Lifecycle Advisory Program. “The device was among 15
Drugs
Sage Therapeutics says the Phase 2 DIMENSION study of dalzanemdor in participants with cognitive impairment associated with Huntington’s disease failed to meet its primary endpoint. A company statement says secondary endpoints also did not show statistically significant or clinically meaningful differences in participants treated with dalzenemdor compared to placebo.
Drugs
A 5/20-5/24 FDA inspection at the Originitalia SRL drug manufacturing facility in Vicenza, Italy, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. An 11/7 Warning Letter says specific violations were: * failure to test samples of each component for full identity and
Drugs
Novo Nordisk is supporting its 10/22 nomination of semaglutide drugs to the lists of drug products that present demonstrable difficulties for compounding (DDC) lists with an 11/13 petition calling on FDA to take three specific actions to promulgate regulations to place the products on the lists. The petition
Drugs
A 4/22-4/25 FDA inspection at the Silliker contract testing laboratory, doing business as Merieux NutriSciences in Gainesville, FL, found violations of current good manufacturing practice (CGMP) regulations for finished drugs. An 11/12 Notice of Violation says specific violations were: * failure to establish adequate written responsibilities and
Drugs
A 5/1-5/14 FDA inspection at the Unexo Lifesciences drug manufacturing facility in New Delhi, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. An 11/6 Warning Letter says specific violations were: * failure of the firm’s quality control unit to exercise
Drugs
A 5/7-5/22 FDA inspection at the Colgate-Palmolive/Tom’s of Maine over-the-counter drug manufacturing facility in Sanford, ME, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. An 11/5 Warning Letter says specific violations were: * failure to follow appropriate
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Frequently Asked Questions — Developing Potential Cellular and Gene Therapy Products.” The document provides industry with answers to frequently asked questions (FAQs) and commonly faced issues that arise during the development of cellular and gene therapy products. The FAQs represent
FDA Policy/General
Federal Register notice: FDA has determined that GlaxoSmithKline’s Jesduvroq (daprodustat) tablets were not withdrawn due to safety or effectiveness reasons. This action will allow the agency to approve ANDAs that reference the product if all other legal and regulatory requirements are met. Jesduvroq is a hypoxia-inducible factor prolyl
Devices
The FDA Digital Health Advisory Committee will consider 11/20-21 FDA questions about the regulation and oversight of generative artificial intelligence (GenAI)-enabled medical devices. A briefing document distributed in advance of the committee meeting says the “novel capabilities of GenAI may offer unique benefits to patients and public
Drugs
FDA has issued Astellas Pharma a complete response letter (CRL) on a supplemental NDA for Izervay (avacincaptad pegol intravitreal solution) seeking revised drug labeling for its use in treating geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The company says the agency’s comments in the CRL are
Drugs
Friends of Cancer Research says an FDA draft guidance on considerations for generating clinical evidence from oncology multiregional clinical development programs is “valuable for addressing key challenges in oncology clinical trials and global drug development programs. We appreciate FDA’s focus on population representativeness, patient diversity, and region-specific analysis.
Drugs
Merck is reporting “positive topline results” from the pivotal Phase 3 MK-3475A-D77 trial that evaluated the noninferiority of subcutaneous administration of Keytruda (pembrolizumab) and berahyaluronidase alfa, a hyaluronidase variant manufactured by Alteogen administered with chemotherapy versus intravenous (IV) Keytruda administered with chemotherapy for the first-line treatment of
Drugs
FDA is seeking input 11/21 from its Cellular, Tissue, and Gene Therapies Advisory Committee about AstraZeneca’s Andexxa (coagulation factor Xa recombinant, inactivated-zhzo) and an increased risk of thrombosis relative to the therapy’s benefits. The therapy was granted accelerated approval in 2018 for patients treated with blood
Drugs
GSK is announcing that its Phase 3 GLISTEN trial evaluating linerixibat, an investigational targeted inhibitor of the ileal bile acid transporter (IBAT), in adults with cholestatic pruritus (relentless itch) associated with primary biliary cholangitis met its primary endpoint. “GLISTEN met its primary endpoint, with linerixibat resulting in an improvement in
Devices
FDA has cleared a BrightHeart 510(k) for its artificial intelligence (AI) software for reviewing prenatal ultrasound evaluations of the fetal heart. The AI software is designed to “improve the detection of morphological abnormalities suggestive of congenital heart defects (CHDs) in resource-constrained practices,” the company says. “Our AI-powered
Drugs
DA is has issued Takeda Pharmaceutical a four-item Form FDA-483 after inspecting the firm’s Yamaguchi, Japan manufacturing facility. Agency investigators found that the facility’s investigations into unexplained discrepancies did not result in written records being created. They also cited Takeda for failing to thoroughly review any