Devices
FDA has denied a Nautilus Glove 1/11 request for reconsideration and petition for stay of action that asked the agency to (1) reconsider its recission of 510(k) substantial equivalence for the Nautilus Nitrile Exam Gloves and permit the company to amend its 510(k) with the correct in
Drugs
The Critical Path Institute (C-Path) says revisions in an FDA draft guidance on developing drugs to treat early Alzheimer’s disease from a 2018 draft “add helpful clarity about strategies to assist sponsors developing treatments for early-stage disease.” The comment letter says this is particularly true in terms
Devices
Medtronic is recalling (Class 1) its StealthStation S8 Application Versions 1.2.0, 1.1.0, 1.0.3, 1.0.2, and 1.0.1 after customer complaints about a software error that removed numbers or letters in displayed text and replaced them by a space, in either the
Devices
A 6/3-6/5/2023 FDA inspection at Trexo Robotics Holdings in Mississauga, Ontario, Canada, found that the firm manufactures the Trexo Home and Trexo Plus medical devices that are adulterated because they do not have an approved PMA or IDE in place. A just-released 2/7 Warning
Biologics
FDA has published a draft guidance, Standardized Format for Electronic Submission for Marketing Applications Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for Center of Biologics Evaluation and Research Submissions, that applies to electronic submissions of data and information from pivotal studies used to support safety and efficacy claims
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Prescription Drug Marketing.” The collection supports the agency’s regulations and statutory requirements that govern prescription drug marketing and requirements for the: (1) reimportation and wholesale distribution of prescription drugs; (2) sale, purchase, or trade of, or
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance for industry entitled “Processes and Practices Applicable to Bioresearch Monitoring Inspections.” The document was mandated by the Food and Drug Omnibus Reform Act of 2022, which directs the agency to issue guidance describing the processes and practices applicable to such
Drugs
The U.S. Pharmacopeia (USP) inaugural drug shortage report shows that shortages are at a decade high and are lasting longer than they did in 2020. A USP statement (includes a link to the report) says that the average drug shortage lasts for over three years, compared to about two
Biologics
An FDA advisory committee 6/5 unanimously voted (16-0) to recommend that Covid-19 vaccine makers formulate their upcoming fall shots to provide protection against the JN.1 variant, which was the most prevalent variant in February. In recent weeks, JN.1 has been less common as “descendants” KP.
Drugs
Amgen is announcing positive topline results from its randomized, placebo-controlled Phase 3 clinical trial (MITIGATE) evaluating the efficacy and safety of Uplizna (inebilizumab-cdon) for treating immunoglobulin G4-related disease (IgG4-RD). Currently, the therapy is approved for neuromyelitis optica spectrum disorder. The company says the trial met its
Drugs
The Biosimilars Council, a division of the Association for Accessible Medicines, says the biosimilar development paradigm in the U.S. should be updated and streamlined to reflect new scientific understandings. In a position paper, the council says an updated development paradigm “must account for scientific advances that allow for the
Drugs
FDA has published a draft guidance, Processes and Practices Applicable to Bioresearch Monitoring Inspections, addressing the types of records and information to be provided, best practices for communication between FDA and industry in advance of or during an inspection or request for records or other information, and other inspection-related
Drugs
A January FDA inspection at Jiangsu Hengrui Pharmaceuticals in Jiangsu, China, resulted in an eight-observation Form FDA-483. Agency inspectors found that the firm’s procedures designed to prevent microbiological contamination of drug products did not include adequate validation of the aseptic and sterilization process. The inspection also found
FDA Policy/General
Federal Register notice: FDA is withdrawing 23 NDAs from multiple applicants after being notified by the application holders that the products were no longer marketed and requesting that they be withdrawn. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Medical Device Recall Authority — 21 CFR Part 810.” The collection supports agency regulations that set forth mandatory medical device recall authority provisions. For example, it covers FDA’s authority to issue a recall order if it finds
Biologics
FDA commissioner Robert Califf and two agency colleagues say FDA is interested in pragmatic clinical research as a “middle path between traditional randomized clinical trials and observational evidence to inform decisions about the use of medical products after initial market approval.” Writing in a JAMA Viewpoint, the three say pragmatic
Drugs
Bristol Myers Squibb says data from the Phase 3 CheckMate-9DW trial evaluating the dual immunotherapy combination of Opdivo (nivolumab) plus Yervoy (ipilimumab) compared to investigator’s choice (lenvatinib or sorafenib) as a first-line treatment for patients with unresectable hepatocellular carcinoma (HCC) showed that the combination had a statistically
Devices
A 6/19-6/22/2023 FDA inspection at Techlem Medical Corporation in Mississauga, Ontario, Canada, found multiple Quality System Regulation violations in the firm’s manufacturing of wheeled stretchers. A just-released 12/26/2023 Warning Letter says the specific violations were: * failure to adequately establish procedures for implementing
Devices
Arrow International has recalled (Class 1) its Arrow FiberOptix Intra-Aortic Balloon Catheter Kit after receiving reports about “infrequent” device malfunctions that could result in serious health consequences. According to a recall notice, the issues may “manifest” as failure of the intra-aortic balloon to completely inflate over its full
Drugs
The Association for Accessible Medicines (AAM) says it appreciates that FDA is issuing a draft guidance on achieving and maintaining data integrity for the clinical and bioanalytical portions of bioavailability and bioequivalence studies submitted to support INDs, NDAs, ANDAs, the bioanalytical portion of clinical pharmacologic studies supporting CDER-regulated biosimilar
FDA Policy/General
Federal Register notice: FDA is issuing an order debarring Michael Terry Little for five years from importing or offering for import any drug into the U.S. The debarment is based on Little’s felony conviction for introducing unapproved new drugs in interstate commerce from 3/2018 to 1/2022
Drugs
Agios Pharmaceuticals plans to submit by the end of the year an NDA for mitapivat and its use in adults with transfusion-dependent alpha- or beta-thalassemia. The move is based on just-announced Phase 3 (ENERGIZE-T) study data that met the primary endpoint of transfusion reduction response. “Statistical