FDA Policy/General
EUA for Abbott’s BinaxNow Revoked 3/18/2022 Federal Register notice: FDA has revoked an Emergency Use Authorization (EUA) issued to Abbott Diagnostics Scarborough for the BinaxNOW Covid-19 Ag Card 2 Home Test. FDA says Abbott never marketed the test under the EUA, and the product is subsequently
FDA Policy/General
OncoImmune has entered into an exclusive option and license agreement with Pfizer for ONC-392, a novel, differentiated preclinical anti-CTLA4 monoclonal antibody, in a deal worth up to $250 million in upfront and potential milestone payments. Under the terms of the agreement, Pfizer plans to evaluate ONC-392 up
FDA Policy/General
Federal Register notice: FDA has revoked an Emergency Use Authorization (EUA) issued to Abbott Diagnostics Scarborough for the BinaxNOW Covid-19 Ag Card 2 Home Test. FDA says Abbott never marketed the test under the EUA, and the product is subsequently marketed and covered by a subsequent EUA. To view
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Evaluation of the Program for Enhanced Review Transparency and Communication for New Molecular Entity New Drug Applications and Original 351(a) Biologics License Applications in Prescription Drug User Fee Acts and 351(k) Biologics License Applications in
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Abbreviated New Animal Drug Applications--Section 512(b)(2) and (n)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(b)(2) and (n)(1))” (OMB Control Number 0910-0669). To view
FDA Policy/General
Federal Register notice: FDA is seeking comments on its draft “Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Exchange” for electronically submitting PQ/CMC data. The document provides a draft design of Health Level 7 (HL7) “Fast Health Interoperability Resources” (FHIR) profiles that contain the data elements and terminologies
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Medical Device Accessories” (OMB Control Number 0910-0823). To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has submitted to OMB and information collection revision entitled “MedWatch: The FDA Safety Information and Adverse Event Reporting Program” (OMB Control Number 0910-0291). The agency is revising the collection to include electronic submission of adverse event reports. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Considerations for the Development of Chimeric Antigen Receptor T Cell Products.” The document includes CAR T cell-specific recommendations regarding chemistry, manufacturing, and control, pharmacology and toxicology, and clinical study design. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is announcing the fee rates under the over-the-counter (OTC) monograph drug user fee program (OMUFA) for fiscal year 2022. The fees are as follows: * OTC monograph order request Tier 1 fee: $507,021 * OTC monograph order request Tier 2 fee: $101,404 * OTC monograph
FDA Policy/General
Federal Register notice: FDA has issued an order to permanently debar Nayade Varona from providing services to anyone having an approved or pending drug product application. FDA bases this order on a finding that Varona was convicted of a felony (guilty plea) while employed as an assistant study coordinator at
FDA Policy/General
A Senate pandemic-related bill that outlines many new FDA responsibilities is headed to the Senate floor for a vote after being marked-up 3/15 by Health, Education, Labor and Pensions (HELP) Committee members. The Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act (PREVENT
FDA Policy/General
Federal Register notice: FDA has revoked the Emergency Use Authorizations issued to LifeHope Labs for the LifeHope 2019-nCoV Real-Time RT–PCR Diagnostic Panel, and Omnipathology Solutions Medical Corp. for the Omni Covid–19 Assay by RT–PCR. Both revocations follow the companies' notification that they no longer
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Current Good Manufacturing Practice and Preventive Controls, Foreign Supplier Verification Programs, Intentional Adulteration, and Produce Safety Regulations: Enforcement Policy Regarding Certain Provisions.” To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has determined that GE Healthcare’s MPI DMSA kidney reagent (Technetium Tc-99m Succimer Kit), Injectable, was not withdrawn from sale for safety or effectiveness reasons. The determination will allow FDA to approve ANDAs referencing the product if all other legal and regulatory requirements are met.
FDA Policy/General
Class 2 for Automated Glycemic Controllers 3/11/2022 Federal Register notice: FDA has classified the interoperable automated glycemic controller into medical device Class 2 (special controls). The action is in response to a Tandem Diabetes Care de novo classification request for its Control-IQ Technology. The agency has identified
FDA Policy/General
Ipsen has completed an acquisition of a portfolio of five international consumer healthcare products from Sanofi: Prontalgine, an analgesic for treating moderate to severe pain; Buscopan, an antispasmodic, Suppositoria Glycerini, a laxative; and Mucothiol and Mucodyne, expectorants for cough and flu. Horizon Pharma has agreed to acquire River Vision Development
FDA Policy/General
DEVICES FDA has cleared a Globus Medical 510(k) for the Excelsius GPS, a robotic guidance and navigation system for orthopedic (screw placement applications in spine and orthopedic surgery) and neurosurgical procedures. The device integrates Globus Medical implants and instruments and is compatible with pre-operative computed tomography (CT), intra-
FDA Policy/General
Federal Register notice: FDA has classified the interoperable automated glycemic controller into medical device Class 2 (special controls). The action is in response to a Tandem Diabetes Care de novo classification request for its Control-IQ Technology. The agency has identified it as a device intended to automatically calculate drug
FDA Policy/General
A Parkland, FL man who was the sales director for Blackstone Labs was sentenced 3/11 to 51 months in prison for conspiring to defraud FDA and conspiring to distribute anabolic steroids. According to a Justice Department release, a jury convicted James Boccuzzi in December for his and the firm’
FDA Policy/General
Federal Register notice: FDA has made available a revised draft guidance entitled “Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs.” The document addresses the verification systems that manufacturers, repackagers, wholesale distributors, and dispensers must have in place to comply with the Federal Food, Drug, and
FDA Policy/General
Federal Register notice: FDA has announced a 4/21-22 Oncologic Drugs Advisory Committee meeting. On 4/21, the panel will discuss the appropriate approach for phosphatidylinositol-3-kinase inhibitors currently under development for use in patients with hematologic malignancies and whether randomized data should be required to support a