Drugs
FDA has released its analysis of FY 2023 institutional review board (IRB) violations based on the form FDA-483s that were issued. The report says that broadly written regulations do not always convey the specific details of the observed violations. The agency says it reviewed and sub-categorized FDA-483
Devices
FDA has granted de novo authorization to LumiThera for its Valeda light delivery system to treat patients with dry age-related macular degeneration (AMD). The company says the Valeda therapy is the first authorized treatment for vision loss in dry AMD patients. “Valeda provides an improvement in best corrected visual
Drugs
FDA has approved Caris Life Sciences’ MI Cancer Seek and its use as a companion diagnostic (CDx) to identify cancer patients who may benefit from treatment with targeted therapies. “The assay includes one pan-cancer and five tumor-specific indications for numerous FDA-approved therapies,” the company says. “MI Cancer
Devices
Although the American Clinical Laboratory Association maintains that FDA lacks authority to regulate laboratory-developed tests (LDTs), it is submitting comments to an agency draft guidance on predetermined change control plans (PCCPs) for medical devices. “In the event that FDA’s final rule to regulate LDTs as medical devices is
FDA Policy/General
President-elect Donald Trump’s top health advisor Robert F. Kennedy Jr. is continuing his criticism of FDA and officials working there, going as far as saying that there a some “departments” and “some categories of workers” that have to go because they are not doing their job. The former
Devices
FDA has granted a breakthrough device designation for SeaStar Medical’s Selective Cytopheretic Device (SCD) to treat chronic systemic inflammation in end-stage renal disease patients who require chronic hemodialysis. A company statement says the SCD is a patented cell-directed extracorporeal device that employs immunomodulating technology to selectively target
Drugs
FDA has released the form FDA-483 issued following a 9/3-9/18 inspection at the Staska Pharmaceuticals outsourcing facility in Bennet, NE. The nine inspection observations were: * failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any
Drugs
Three stakeholder organizations are asking FDA to revise the Risk Evaluation and Mitigation Strategy (REMS) for the psychiatric drug clozapine to reduce its barriers to treatment for many patients. In its comment for a joint meeting of the Drug Safety and Risk Management Advisory Committee and the Psychopharmacologic Drugs Advisory
Devices
FDA has cleared a Zeta Surgical 510(k) for its Zeta Navigation System for use with expanded instruments and enhanced hospital connectivity. The device is designed to provide “rapidly deployable, high-accuracy navigation” for neurological interventions currently unsupported by existing navigation systems, according to the company “Its GPS-like guidance
Devices
FDA is asking members of its General and Plastic Surgery Advisory Committee to comment on the risks and benefits of IceCure Medical’s ProSense cryoblation system intended to be used in patients with early-stage, low-risk breast cancer as an alternative to breast-conserving surgery (lumpectomy). A briefing paper
Drugs
An FDA 11/2-11/8/2023 Bioresearch Monitoring Program inspection at the Armstrong County Memorial Hospital Institutional Review Board (IRB) in Kittanning, PA., found “objectionable conditions” indicating that the IRB did not adhere to applicable statutory requirements on the protection of human subjects. A 10/29 Warning Letter emphasized
Drugs
In an NPR interview, FDA commissioner Robert Califf says the field of artificial intelligence will be so big that FDA couldn’t possibly hire enough people to regulate it alone. “It’s very important that we get the clinical community, the health systems, the professions, the people you see for
Drugs
Acadia Pharmaceuticals says it is selling its Rare Pediatric Disease Priority Review Voucher (PRV) for $150 million to an undisclosed buyer. The PRV was awarded to Acadia 3/2023 following FDA approval of the company’s Daybue (trofinetide) for treating Rett syndrome. The company says the sale proceeds will support
Devices
FDA has approved an Envoy Medical IDE for its pivotal study of the Acclaim Fully Implanted Cochlear Implant, an implanted sensor that the company says is designed to leverage the natural anatomy of the ear to capture sound. The agency approved the IDE application as a staged clinical study, which
Drugs
FDA has extended by three months its review of an Organon supplemental NDA for Vtama (tapinarof) cream, 1%, for treating atopic dermatitis in adults and children two years of age and older. The revised user fee review action target date is 3/12/2025. During its review, FDA requested the
Drugs
An FDA review of records submitted by Shandong Boyuan Pharmaceutical Co. in Shandong, China, at the agency’s request, identified current good manufacturing practice (CGMP) deviations in the firm’s manufacturing of active pharmaceutical ingredients (APIs). A just-released 10/17 Untitled Letter says the specific deviations were: * failure to
Drugs
A 5/17-5/17 FDA inspection at the Analytical Food Laboratories contract testing laboratory in Grand Prairie, TX, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 10/10 Warning Letter says specific violations were: * failure to establish and follow required laboratory
Devices
FDA has cleared a SimBioSys 510(k) for TumorSight Viz to expand its use by breast surgeons by processing images using artificial intelligence (AI). According to the company, the AI processing delivers “accurate and efficient tumor and tissue segmentation, enabling detailed 3D spatial visualization to support treatment planning.” The digital
Biologics
FDA has extended by three months its priority review of a Merus BLA for Zeno (zenocutuzumab) for treating patients with neuregulin 1 fusion (NRG1+) non-small cell lung (NSCLC) and NRG1+ pancreatic (PDAC) cancer. The extension will give FDA additional time to review information recently submitted in response to a
Biologics
Four stakeholders — St. Jude Children’s Research Hospital, the National Organization for Rare Disorders (NORD), the Muscular Dystrophy Association (MDA), and the Biotechnology Innovation Organization (BIO) — are voicing support for an FDA proposal to create an FDA Rare Disease Innovation Hub (RDI Hub). The four also respond to FDA questions
Devices
Attorney Bradley Thompson (Epstein Becker Green) says his review of the FDA consensus standards database indicates that CDRH “is not yet investing enough time and energy in recognizing standards to support digital health and the adoption of artificial intelligence.” Writing online in Health Law Advisor, Thompson also says he is
Drugs
FDA is announcing a new opportunity for drug companies to participate in a pilot program designed to expedite the review of new therapies addressing unmet medical needs. Starting 12/2 , CDER and CBER will each accept one to two original marketing applications as part of the STAR pilot program. The