FDA Policy/General
Federal Register notice: FDA has created a docket to receive comments on changes to the agency’s previously proposed quality metrics reporting program. The agency is considering revamping the program based on lessons learned from two 2018-announced pilot programs with industry, a site visit program, and stakeholder feedback on
FDA Policy/General
FDA would see a $102 million (3.2%) boost to its discretionary funding from Congress under a House and Senate Appropriations omnibus bill introduced 3/9 that covers 12 FY 2022 spending bills. Currently, FDA has been operating under a continuing resolution that has kept its spending level at FY
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under Docket No. FDA-1977-N-0015 (formerly 77N-0187) as part of the Drug Efficacy Study Implementation have been withdrawn.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
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
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
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
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,
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
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
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Emergency Use Authorization of Medical Products” (OMB Control Number 0910-0595). The collection helps support implementation of agency policies applicable to authorizing medical products for use in emergencies under sections 564, 564A, and 564B of the Federal
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Inclusion of Older Adults in Cancer Clinical Trials.” The document provides recommendations about including older adult patients (aged 65 and older) in oncology drug clinical trials. It also emphasizes the importance of including adults over age 75 years in
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Expansion Cohorts: Use in First-in-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics.” The document provides advice on multiple expansion cohort trial designs for investigational oncology drugs. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics.” The document provides advice to sponsors about the design and conduct of clinical trials intended to simultaneously evaluate more than one investigational drug and/
FDA Policy/General
Former FDA director of orphan product development Timothy Cote is petitioning the agency to “immediately and completely freeze all administrative actions on any regulatory requests from pharmaceutical and medical device companies headquartered in Russia or with majority Russian ownership.” His 2/22 emergency petition cites the Russian invasion of Ukraine
FDA Policy/General
Federal Register notice: FDA is classifying the screw sleeve bone fixation device into Class 2 (special controls). The action was taken in response to a Woven Orthopedic Technologies de novo classification request for its OGmend Implant System, which is intended to be implanted in conjunction with a non-resorbable, metallic
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Patient-Focused Drug Development: Methods To Identify What Is Important to Patients.” The document describes how to collect and submit information from patients and caregivers to be used for medical product development and regulatory decision making. To view the
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of an Elanco new animal drug application (NADA 093–329) for use of a prolonged-release bolus containing sulfamethazine in cattle because the product is no longer manufactured or marketed. The sponsor requested the action because the product is no longer manufactured or