Devices
A 3/21-5/10 FDA inspection at a Criticare Technologies medical device operation in Warwick, RI, found that the patient monitors it manufactures, including the nGenuity patient vital signs monitor, are adulterated due to violations of the Quality System regulation. A 7/12 Warning Letter says specific violations were:
Devices
FDA has posted a Web page of frequently asked questions (FAQs) about its new final rule on laboratory-developed tests (LDTs). The post covers definitions and general oversight, phaseout policy and enforcement discretion policies, labeling, premarket review, investigational use, specific test categories or technologies, and resources and interactions with FDA.
Drugs
Merck is reporting positive topline results from its Phase 2b/3 clinical trial (MK-1654-004) evaluating clesrovimab (MK-1654), an investigational prophylactic monoclonal antibody designed to protect infants from respiratory syncytial virus (RSV) disease. Clesrovimab met its primary safety and efficacy endpoints in the trial, including reducing medically attended
Drugs
Experts from FDA, the American Association for Cancer Research (AACR), and the American Statistical Association (ASA) have published considerations for clinical trial designs to enhance the collection and analysis of overall survival data in the context of modern-day cancer treatments. The work was published in Clinical Cancer Research. An
Biologics
FDA has accepted a Genentech supplemental BLA for Susvimo (ranibizumab injection) 100 mg/mL, indicated for treating diabetic macular edema (DME) and diabetic retinopathy (DR), the two leading causes of vision loss in adults with diabetes. Susvimo is the first refillable eye implant that provides continuous delivery of ranibizumab through
Devices
FDA has cleared a Think Surgical 510(k) for its Tmini Miniature Robotic System with Tmini 1.1. software for total knee arthroplasty procedures. The device’s Tmini PRO workflow “enables positional refinement and optimization” of the implant tailored to a patient’s needs, the company says. “The workflow’s
Biologics
FDA is planning to ask an advisory committee 7/25 whether a new trial should be conducted before approving an AstraZeneca supplemental BLA for Imfinzi (durvalumab) injection that is seeking its use in combination with platinum-containing chemotherapy as neoadjuvant treatment. The application proposes that this would then be followed
FDA Policy/General
Federal Register notice: FDA is correcting a 7/2 notice that announced the determination of the regulatory review period for Sanofi’s Xenpozyme (olipudase alfa-rpcp) for patent extension purposes. The document was published with an incorrect patent number, and this notice corrects that. To view the notice, click here.
Drugs
Johnson & Johnson has filed a supplemental NDA seeking approval of Spravato (esketamine) nasal spray as monotherapy for adults living with treatment-resistant depression (TRD). “Many patients living with challenging-to-treat depression spend far too long cycling through multiple treatments that don't effectively resolve their symptoms, which
Biologics
FDA has approved a Samsung Bioepis BLA for Epysqli (eculizumab-aagh) as a biosimilar to Alexion’s Soliris (eculizumab), indicated for treating patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis, and atypical hemolytic uremic syndrome. The approval was based on a “totality of evidence” including analytical, non-clinical and
FDA Policy/General
New studies by FDA drug promotion staff found that consumers conflated a drug’s benefits and risks when they were exposed to both a disease awareness communication and drug advertisement. “Participants more often incorrectly attributed benefits of using the drug to treat or manage the disease (asthma) when the disease
Drugs
Ionis Pharmaceuticals says data from its Phase 1/2 open-label study of ION582 in people with Angelman syndrome demonstrated consistent and encouraging clinical improvement on measures assessing all “functional domains” including communication, cognition and motor function. “Overall, 97% of people in the medium and high dose groups saw an
Drugs
FDA has cleared a Varian 510(k) for new functionality to its Ethos radiotherapy system for treating cancer. The latest version of the device introduces a streamlined workflow for daily treatment adaptation across more areas of the body, and provides greater connectivity to patient data to make it easier to
Devices
FDA has granted Tulavi Therapeutics a de novo marketing authorization for its Allay Nerve Cap, described as a fully absorbable in situ forming hydrogel that is designed to protect transected nerves, prevent axonal escape, and reduce the risk of neuroma formation. When peripheral nerves are cut during amputation, they attempt
Devices
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Drugs
FDA has posted a draft guidance entitled “Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products; Questions and Answers.” The document provides answers to common questions from applicants and other interested parties about postapproval manufacturing made to licensed biosimilars and interchangeable biosimilars. It is intended to inform applicants about the
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection entitled “Diversity Action Plans (DAPs) for Clinical Studies.” The collection supports Sections 3601 and 3602 of the Food and Drug Omnibus Reform Act of 2022 that stipulates that a DAP must include the sponsor’s goals for enrollment in
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Pediatric Inflammatory Bowel Disease: Developing Drugs for Treatment.” The document provides FDA’s recommendations about the necessary attributes of clinical studies for drugs being developed for treating pediatric ulcerative colitis or pediatric Crohn’s disease, including study population, study
Devices
Mainz Biomed has submitted an application requesting a breakthrough device designation for what it calls its non-invasive next-generation colorectal cancer test including the company’s portfolio of messenger (mRNA) biomarkers. The submission is based on data read-outs of its clinical studies ColoFuture and eAArly Detect, as well
Devices
FDA is announcing an 11/6 public workshop entitled “Accreditation Scheme for Conformity Assessment and Use of Chemical Analysis to Support Biocompatibility of Medical Devices.” The workshop is intended for the agency to discuss the expansion of the Accreditation Scheme for Conformity Assessment (ASCA) program to include chemical analysis to
Drugs
FDA has granted Diamyd Medical a Fast Track designation for Diamyd (rhGAD65/alum) for use in treating Type 1 diabetes in pediatric patients with Stage 1 or Stage 2 Type 1 diabetes carrying the genotype HLA DR3-DQ2. Earlier this year, Diamyd was granted fast track for treating Stage 3
Devices
FDA has cleared a Heidelberg Engineering 510(k) for its Spectralis optical coherence tomography angiography (OCTA) Module with SHIFT technology, which is claimed to reduce acquisition time by 50%. The preset OCTA speed of 125 kHz is designed to enhance clinical efficiencies and maintain image quality, the company says. “Combined