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TXT Put T-Cell Assessment in Covid-19 Vaccine Trials: Scientists [2706 Words] [ Price : $8.95]
More than 65 scientific experts call on FDA to recommend that Covid-19 vaccine developers assess T-cells in addition to antibodies in vaccine trials.
04/21/2022
 
 
TXT Docket Established for Opioid Disposal [80 Words] [ Price : $8.95]
Federal Register notice: FDA creates a docket to solicit public comments on a potential modification to its Opioid Analgesic Risk Evaluation and Mitigation Strategy to require that mail-back envelopes for safe disposal option.
04/21/2022
 
 
TXT Annual Report on Postmarketing Commitments [97 Words] [ Price : $8.95]
Federal Register notice: FDA makes available an annual report entitled “Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments.”
04/21/2022
 
 
TXT FDA OKs Production at Kite CAR T-Cell Facility [2673 Words] [ Price : $8.95]
FDA approves commercial production at a new Kite CAR T-cell manufacturing facility in Maryland.
04/21/2022
 
 
TXT 3 Philips Ventilator Recalls Class 1 [2627 Words] [ Price : $8.95]
FDA says recalls of the Philips Respironics V60, V60 Plus, and V680 Plus ventilators are Class 1.
04/21/2022
 
 
TXT Modifications to Device Recognized Standards [80 Words] [ Price : $8.95]
Federal Register notice: FDA announces modifications to its list of standards the agency recognizes for use in premarket reviews.
04/21/2022
 
 
TXT Breakthrough Granted to Donor Heart Transport Device [97 Words] [ Price : $8.95]
FDA grants Bridge to Life a breakthrough device designation for its LifeCradle Heart Preservation Transport System, intended to provide preservation, storage, monitoring, and transportation of donor hearts.
04/21/2022
 
 
TXT NAC Product Enforcement Discretion Guidance [2782 Words] [ Price : $8.95]
FDA publishes a draft guidance explaining its enforcement discretion for dietary supplements containing N-acetyl-L-cysteine.
04/21/2022
 
 
TXT Covid Vaccine for Kids Under 5 May Come in June: NBC [2711 Words] [ Price : $8.95]
NBC News reports FDA may authorize Covid vaccinations for children under age 5 in June.
04/21/2022
 
 
TXT Nanomaterial Drug, Biologic Product Guidance [2729 Words] [ Price : $8.95]
FDA issues a finalized guidance on developing human drug products that contain nanomaterials.
04/21/2022
 
 
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