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February 26, 2020 Drug & Device Advisory Group Link and Learn Clinical Trial of Remdesivir to Treat COVID-19 NIH (NIAID) Clinical Trial of Remdesivir to Treat COVID-19 Begins Randomized, controlled clinical trial to evaluate the safety and efficacy of the investigational antiviral REMDESIVIR in hospitalized adults diagnosed with COVID-19  Remdesivir is an investigational broad-spectrum antiviral […]

June 21, 2018 Drug & Device Advisory Group Link and Learn Mobile App for Drug Shortages FDA Drug Shortages Mobile App CDER Drug Shortages Staff (DSS) works with pharmaceutical manufacturers, review divisions, compliance and other components of FDA to manage product shortages Easy to use App to quickly locate current drug shortages and other important information

Month: May 2021 May 2, 2021 Drug & Device Advisory Group FDA Briefs News and Views: Janssen COVID vaccine pause lifted, Guidance for developing COVID drugs, New pharmacometrics approach, Standards to ban menthol cigarettes, CDRH patient science, Opioid safe disposal, Colorectal cancer screening FDA and CDC Lift Recommended Pause on Janssen Vaccine Use Following Thorough

September 19, 2016 Drug & Device Advisory Group Link and Learn FDA Division of Biology, Chemistry, and Materials Science WHAT: Part of  Office of Science and Engineering Laboratories (OSEL), CDRH WHY: Determine effects of implanted devices, potential device adverse effects,  source and impact of device degradation Develop experimental data, test methods, and protocols Develop measurements,

June 22, 2015 Drug & Device Advisory Group Other Habitual chocolate consumption could reduce the risk of cardiovascular disease Authors in a study examined the association between chocolate intake and the risk of future cardiovascular events in total of 20951 men and women. Authors evaluated chocolate consumption and cardiovascular outcomes. Results suggested that higher chocolate

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:

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