Devices
FDA has released a final guidance entitled Refuse to Accept Policy for 510(k)s that outlines the procedures and criteria the agency intends to use in assessing whether a medical device premarket notification (510(k)) submission meets a minimum threshold of acceptability and should be accepted for substantive review.
Drugs
Biogen has withdrawn a European marketing authorization application for its troubled Alzheimer’s drug aducanumab. This is the latest chapter for the therapy, which gained FDA accelerated approval 6/7/21 that ignited a firestorm of criticism and the resignation of several advisory committee members. In the aftermath, then-acting
Drugs
FDA has accepted for review a Revance Therapeutics BLA resubmission for DaxibotulinumtoxinA for Injection, indicated for treating moderate to severe glabellar lines, in response to a 10/2021 Complete Response Letter. The agency has set a 9/8 user fee review action date. The company says the submission adheres to
FDA Policy/General
Federal Register notice: FDA is withdrawing six compliance policy guides (CPGs) because they contain duplicative information or they no longer reflects the agency’s current thinking. The affected CPGs are: · CPG Sec.500, Razor Blades, Manicuring Instruments — Not Considered Devices Under 201(h) · CPG Sec. 310.200, Sphygmomanometers — Rx Legend
Drugs
FDA is encouraging the pharmaceutical industry to comment on its project to identify and prioritize pharmaceutical quality (PQ) and chemistry and manufacturing and controls (CMC) information that would benefit from a structured electronic submission approach. “Standardizing the format of structured data submission standardized format should increase the efficiency of FDA’
Biologics
A 4/21 letter signed by 69 experts working in academic centers, companies, and non-profit organizations is urging FDA to include a recommendation for T-cell assessment in its guidance to vaccine developers for Covid-19 vaccine trials. The letter says that “measuring T-cell responses in addition to
FDA Policy/General
Federal Register notice: FDA has established a docket to solicit public comments on a potential modification to its Opioid Analgesic Risk Evaluation and Mitigation Strategy to require that mail-back envelopes be dispensed along with education on safe disposal provided with opioid analgesics dispensed in an outpatient setting. To view
FDA Policy/General
Federal Register notice: FDA has made available an annual report entitled “Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments.” Under the Federal Food, Drug, and Cosmetic Act, the agency is required to report annually on the status of postmarketing requirements and postmarketing commitments
Drugs
FDA has approved commercial production at the new Kite CAR T-cell therapy manufacturing facility in Frederick, MD. Kite is a Gilead subsidiary. The site will produce Kite’s FDA-approved CAR T-cell therapy used to treat blood cancer, a company statement says. The statement says CAR T-cell
Devices
FDA says recalls of the Philips Respironics V60 ventilator, V60 Plus ventilator, and V680 Plus ventilator were all Class 1. In each instance, Philips says ventilator units have been identified to have an issue affecting an internal electrical circuit that in some cases could potentially result in the ventilator failing
FDA Policy/General
Federal Register notice: FDA is announcing modifications to its list of standards the agency recognizes for use in premarket reviews. “Modifications to the List of Recognized Standards, Recognition List Number: 057” is intended to assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical
Devices
FDA has granted Bridge to Life a breakthrough device designation for its LifeCradle Heart Preservation Transport System, intended to provide preservation, storage, monitoring, and transportation of donor hearts using hypothermic, oxygenated, nutrient perfusion from the time of organ procurement until transplantation into a recipient. “The inherently intuitive system utilizes a
Drugs
FDA has published a draft guidance, Policy Regarding N-acetyl-L-cysteine, explaining the agency’s intent to exercise enforcement discretion for the sale and distribution of certain NAC-containing products that are labeled as dietary supplements. An agency statement says the enforcement discretion policy would apply to products that
Biologics
NBC News says two people familiar with the plans have indicated that FDA could authorize a Covid-19 vaccination for children under age 5 in June. The report says the agency has asked members of its Vaccines and Related Biological Products Advisory Committee to set aside several days in June
Drugs
FDA has published a guidance, Drug Products, Including Biological Products, that Contain Nanomaterials, providing guidance on the development of human drug products, including those that are biological products, in which a nanomaterial is present in the finished dosage form. The document says FDA does not categorically judge all products containing
Drugs
FDA has accepted for review a GlaxoSmithKline NDA for daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor for treating patients with anemia related to chronic kidney disease. The agency has set a 2/1/2023 user fee review action target date. The submission is based on data from the
Drugs
FDA’s Oncologic Drugs Advisory Committee 4/21 voted unanimously 16-0 (one abstention) to recommend that the agency require future approvals of phosphatidylinositol 3-kinase (PI3K) inhibitors be supported by randomized clinical trial data. Panel members agreed with FDA reviewers’ concerns about toxicity and using overall response rates in
Devices
The National Evaluation System for Health Technology Coordinating Center (NESTcc), created by the Medical Device Innovation Consortium, is partnering with Aetion, a real-world evidence (RWE) analytics provider, in a five-year effort to advance the use of RWE in medical devices and diagnostics. An announcement says that as part
Drugs
FDA will accept comments for 60 days to a new public docket established on a potential modification to the Opioid Analgesic Risk Evaluation and Mitigation Strategy to require that mail-back envelopes be dispensed and education on safe disposal provided with opioid analgesics dispensed in an outpatient setting. In a
Drugs
AbbVie has terminated its partnership with BioArctic AB to develop its portfolio of alpha-synuclein antibodies, including ABBV-0805 — a humanized monoclonal antibody targeting alpha-synuclein being investigated for treating Parkinson’s Disease. Their collaboration began in 2016 and in 2019 a Phase 1 study of ABBV-0805 was started.
Devices
FDA will hold a three-day virtual public workshop on “Building Medical Device Supply Chain Resilience: A Healthcare and Public Health Ecosystem-Wide Collaboration” on 6/7-9. A meeting announcement says the workshop is to discuss ways to foster resiliency in the medical device supply chain and to seek
Drugs
A CDER podcast gives drug companies the key elements in being “recall-ready.” The podcast refers to a final guidance that outlines preparations that firms should consider making to establish recall initiation procedures to ensure faster and more accurate recall actions. “FDA encourages companies to communicate quickly with supply chain