Devices
An 8/19-9/17/21 FDA inspection at CardioQuip, College Station, TX, found Quality System Regulation and other issues in the firm’s manufacturing of a cardiac heater-cooler product in various configurations. A just-released 2/11 Warning Letter says the firm holds an 11/19/2010 510(
FDA Policy/General
Federal Register notice: FDA has announced that all outstanding hearing requests regarding potassium aminobenzoate tablets, capsules, powder, and envules under Docket No. FDA-1977-N-0015 (formerly 77N-0187) as part of the Drug Efficacy Study Implementation have been withdrawn. Therefore, FDA has determined that the products have not been
Drugs
The National Academies Committee on Security of America’s Medical Product Supply Chain makes seven recommendations for FDA, other government agencies, and other stakeholders to take to increase the resilience of the medical product supply chain. In a report (purchase or free PDF download) mandated by the 2020 CARES Act,
Devices
FDA has cleared a Pearl 510(k) for its Second Opinion, an artificial intelligence radiologic detection aid intended to help dentists identify numerous common dental problems, including tooth decay, calculus, and root abscesses. The device applies “computer vision” to “identify and highlight key pathologic and nonpathologic findings, including dental caries,
Drugs
CDER has released its FY 2021 GDUFA Science and Research Report that updates stakeholders on the development of innovative methodologies and more efficient tools to help establish drug equivalence standards to support generic drug development. Much of the research is focused on complex products, which often have few generics or
Drugs
FDA is soliciting comments on specific aspects of changes it is proposing to the drug quality metrics reporting program. The changes arise from two pilot programs with industry that were first announced in 2018, a Federal Register notice says. The notice says FDA believes that a change in the entities
Devices
FDA says a cybersecurity vulnerability has been identified for the Axeda agent and desktop server used in numerous medical devices across several manufacturers. All versions of both technologies are affected, the agency says in an online notice. The Axeda agent and desktop server are Web-based technologies that allow one
Drugs
An Illinois federal court has ordered Salud Natural Entrepreneur, Waukegan, IL, to stop distributing dietary supplements that violate the Federal Food, Drug, and Cosmetic Act (FFDCA). A Department of Justice statement says the company and its owner, production manager, and quality control manager violated the FFDCA by distributing adulterated and
Drugs
Mallinckrodt has agreed to pay $260 million to resolve allegations that it violated the False Claims Act by knowingly underpaying Medicaid rebates due for its drug H.P. Acthar Gel, and using a foundation as a conduit to pay illegal co-pay subsidies for the product in violation of the
Drugs
FDA has denied a 9/12/2013 petition submitted by two Weill Cornell Medical Center doctors asking that the agency add a warning to labeling for over-the-counter (OTC) drugs with anticholinergic effects. The FDA response says the petition stated that the impairment of thinking caused by the ingredients
Drugs
Regeneron says an FDA draft guidance on considerations for using real-world data (RWD) and real-world evidence (RWE) to support regulatory decision-making for drug and biological products should acknowledge the rapidly advancing state of science about RWE. “This guidance should make clear that this is a dynamic topic
Drugs
Revance Therapeutics has resubmitted its BLA for DaxibotulinumtoxinA for Injection, indicated for treating moderate to severe glabellar lines, in response to a 10/21 Complete Response Letter. The company says the submission adheres to input it received 12/2021 during a Type A meeting. Specifically, it says it contains information
Devices
A 9/6-9/14/2021 FDA inspection at Wickimed Medical Equipment Manufacturing Company, HuiZhou, China, found Quality System Regulation and Medical Device Reporting violations in the firm’s manufacturing of Class 2 sterile single-use disposable electrodes. A just-released 1/7 Warning Letter says specific violations were: * failing
Drugs
FDA has accepted for priority review a Servier supplemental NDA for Tibsovo (ivosidenib tablets) as a potential treatment for patients with previously untreated IDH1-mutated acute myeloid leukemia (AML). The submission is based on data from the AGILE study, a global Phase 3 trial in patients with previously untreated IDH1-
FDA Policy/General
Federal Register notice: FDA has updated its listing of guidance documents on the Covid–19 public health emergency. FDA notes that the documents were implemented without prior comment, but they remain subject to comment under the agency’s good guidance practices. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has revoked the Emergency Use Authorizations (EUAs) issued to Bio-Rad Laboratories for the BioPlex 2200SARS–CoV–2 IgG, and Quotient Suisse SA for the MosaiQ Covid–19 Antibody Magazine. The agency revoked EUA for the BioPlex device because it was never commercialized, and the EUA
Drugs
Gilead Sciences says results from its Phase 3 TROPiCS-02 study evaluating Trodelvy (sacituzumab govitecan-hziy) in patients with HR+/HER2-metastatic breast cancer showed that the therapy met its primary endpoint with a statistically significant improvement in progression-free survival (PFS) versus physician’s choice of chemotherapy. Patients on
Drugs
FDA has placed a partial clinical hold on Alpine Immune Sciences’ NEON-2 trial evaluating davoceticept (ALPN-202) in combination with pembrolizumab (Merck’s Keytruda) in adults with advanced malignancies. The regulatory hold was the result of Alpine’s report of a Grade 5 serious adverse event (patient death) in
Drugs
House Energy and Commerce Committee chairman Frank Pallone (D-NJ) has introduced the Accelerated Approval Integrity Act that would revamp FDA’s accelerated approval program. Accelerated approval reform has been under a microscope lately following FDA’s controversial approval for Biogen's Alzheimer’s therapy Aduhelm (aducanumab). It has
Drugs
FDA has approved Bristol Myers Squibb’s Opdivo (nivolumab) 360 mg (injection for intravenous use) for adult patients with resectable non-small cell lung cancer (NSCLC). The approval came five days after the company said the submission was accepted for priority review and having a 7/13 user fee review
Devices
FDA has granted Merit Medical Systems a breakthrough device designation for its Embosphere Microspheres for use in genicular artery embolization (GAE) procedures. GAE is intended to reduce pain and disability caused by knee osteoarthritis by reducing blood flow to the knee and minimizing the inflammatory process. Merit Medical says its
FDA Policy/General
Patrick Bishop Debarred for 5 Years 3/4/2022 Federal Register notice: FDA has issued an order to debar Patrick Charles Bishop for a period of five years from importing or offering for import any drug into the U.S. The agency based its action on Bishop’s felony conviction