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
FDA Policy/General
PerkinElmer has entered into a definitive agreement to acquire EuroImmun Medical Diagnostics for $1.3 billion in cash. EuroImmun has expertise and capabilities across immunology, cell biology, histology, biochemistry and molecular biology. Bristol-Myers Squibb has agreed to sell its small molecule active pharmaceutical ingredient manufacturing facility in Swords, Ireland
FDA Policy/General
DEVICES FDA has approved an Intersect ENT PMA for its Propel Contour steroid releasing sinus implant. The device features an hourglass design for treating patients with chronic sinusitis in the frontal (behind the forehead) and maxillary (behind the cheeks) sinuses. It also has a low-profile flexible delivery system to
Biologics
FDA has declined to grant Ocugen an emergency use authorization for Covaxin for active immunization to prevent Covid-19 in individuals aged two to 18 years of age. Ocugen says it plans to work with FDA to evaluate the regulatory pathway for the pediatric vaccine. Last year, Ocugen teamed with
FDA Policy/General
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 for importing an unapproved drug. To view the notice,
Biologics
Sanofi has petitioned FDA requesting that it mandate a labeling change to Seqirus’ influenza vaccine products Fluad and Fluad Quadrivalent to reflect that a confirmatory study failed to verify clinical benefit. The request is presumably intended to give Sanofi a competitive edge for its Fluzone Quadrivalent influenza vaccine. Sanofi’s
Drugs
CDER says it has multiple efforts underway to support rare disease drug development, particularly through data sharing initiatives that are important to advance development in this area. For example, the Center is working with the Critical Path Institute to develop the Rare Disease Cures Accelerator-Data and Analytics Platform, which
Drugs
FDA has issued South Korea-based GC Pharma a complete response letter on its BLA for GC5107 (immune globulin intravenous (human), 10% Liquid) because the agency could not conduct a pre-license inspection of its Ochang facility. “We will continue to communicate with the FDA to coordinate the required onsite
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C.” The document provides input on timely initiation of voluntary recalls of FDA-regulated products. It also discusses preparations that firms in a distribution chain should consider making to
FDA Policy/General
Federal Register notice: FDA is issuing an order to debar George Kuiper for a period of five years from importing or offering for import any drug into the U.S. The order is based on a finding that Kuiper was convicted of multiple felony offenses: One count of smuggling, one
Devices
FDA has granted DexCom a breakthrough device designation for its Dexcom real-time continuous glucose monitoring (CGM) system for use in the hospital setting. The designation is based on data from the company’s exploratory studies over the past seven years that found the device improves glucose control without any
Drugs
Sens. Susan Collins (R-ME) and Shelley Capito (R-WV) are asking the Centers for Medicare and Medicaid Services (CMS) to ensure that its national coverage determination on Biogen’s Aduhelm (aducanumab) and other monoclonal antibody Alzheimer’s drugs does not restrict access and impede research into the disease. In
Drugs
FDA has extended by three months its review of a TG Therapeutics BLA and supplemental NDA for ublituximab in combination with Ukoniq (umbralisib) as a treatment for patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). The agency told the company that updated overall survival analyses, which were
Drugs
Median Technologies has filed a 513(g) submission seeking FDA guidance on the best path to market for its iBiopsy Lung Cancer Screening Artificial Intelligence/Machine Learning technology-based end-to-end CADe/CADx Software as Medical Device. The submission should give Median information to determine the best product classification
Devices
FDA has cleared a Circa Scientific 510(k) for its S-CATH M Esophageal Temperature Probe which can be visualized on 3D cardiac mapping systems during cardiac ablation procedures. The multi-sensor probe is intended to provide high-density, edge-to-edge coverage of the esophagus, and being visualized on
Drugs
Civica says it will manufacture and distribute as early as 2024 three insulins that, once approved, will be available to patients with diabetes at significantly lower prices than products currently on the market. A company statement says it will produce glargine, lispro, and aspart, which are biologics that are interchangeable
FDA Policy/General
Federal Register notice: FDA is permanently debarring Eduardo Navarro from providing services related to an approved or pending drug product application. FDA bases this order on Navarro’s felony conviction related to his conduct as a sub-investigator at Tellus Clinical Research. Navarro and his co-conspirators fabricated medical records
FDA Policy/General
Federal Register notice: FDA is publishing recent information collections that have been approved by OMB. They are: * Labeling Requirements for Human Prescription Drug and Biological Products (0910–0572) * Biosimilar User Fee Program (0910–0718) * Labeling of Certain Beers Subject to the Labeling Jurisdiction of the FDA (0910–0728) * Obtaining Information
Drugs
FDA has published a guidance, Initiation of Voluntary Recalls Under 21 CFD Part 7, Subpart C, to clarify agency recommendations on timely initiation of voluntary recalls and help companies to be “recall ready.” The document discusses what preparations firms in a distribution chain, including manufacturers and distributors, should consider making
Drugs
A Los Angeles Times analysis is joining the chorus of those raising questions about FDA’s use of accelerated approval pathways for drugs whose benefit has not been shown in clinical trials. The newspaper’s report, reprinted by Yahoo! Finance, says that 14 of the 50 (28%) new drugs approved
Drugs
The 837 medical device recalls in 2021 were 20.2% lower than the 10-year annual average of 1,049 recalls, according to the Sedgwick recall index for 2021. The report shows that software issues remained the top cause for recalls, accounting for 162 events (19.4%). The number of