November 2, 2016 Drug & Device Advisory Group FDA Briefs FDA Facts: Abuse-Deterrent Opioid Medications WHAT: FDA Website on FDA standards for Abuse-Deterrent (AD) opioid formulations WHY: To help drug makers expedite regulatory path to market as quickly as possible. FDA is taking a flexible, adaptive approach to the evaluation and labeling of potentially AD products. WHICH: […]
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FDA BRIEF: Week of September 12, 2016 Evaluating FDA’s Approach to Cancer Clinical Trials By: Richard Pazdur, M.D., Acting Director, FDA Oncology Center of Excellence FDA Oncology Center of Excellence (OCE) announced 2 months ago OCE and Cancer Moonshot focus leverage combined expertise in drugs, biologics, and device most innovative approaches for new oncology prod
March 3, 2020 Drug & Device Advisory Group Link and Learn Increased availability of NIOSH approved respirators to healthcare personnel FDA and CDC take action to increase access to respirators, including N95s, for health care personnel FDA-CDC collaboration to prioritize access to needed medical products through Emergency Use Authorization (EUA) Certain industrial respirators during the
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FDA Approvals: SENTOSA ZIKV Test, MINIMED 670G SYSTEM Drug & Device Advisory Group 2 years ago Advertisements FDA BRIEF: Week of September 26, 2016 SENTOSA ZIKV RT-PCR Test Vela Diagnostics USA, Inc. Fairfield, NJ, USA INTENDED USE: The Sentosa® SA ZIKV RT-PCR Test is a real-time RT-PCR test intended for the qualitative detection of RNA from
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Influenza Virus Vaccine for the 2018-2019 Season Flu vaccine lots for 2018-2019 season have been released by FDA and are available for distribution by the manufacturers Afluria, Afluria Quadrivalent, Fluad, Fluarix Quadrivalent, Flucelvax Quadrivalent, Flublok Quadrivalent, FluLaval Quadrivalent, Fluzone Quadrivalent Selected by FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) Reviewed and evaluated surveillance data related to epidemiology and antigenic characteristics
