Archive for May 19, 2021

FDA In Brief: FDA Authorizes Longer Time for Refrigerator Storage of Thawed Pfizer-BioNTech COVID-19 Vaccine Prior to Dilution, Making Vaccine More Widely Available

The following quote is attributed to Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research Making COVID-19 vaccines widely available…

FDA In Brief: FDA Issues Draft Guidance on Early Clinical Studies for Certain Medical Devices to Improve Glycemic Control for Type 2 Diabetes

The following quote is attributed to Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health “As part of our commitment to…

FDA In Brief: FDA Advises Against Use of SARS-CoV-2 Antibody Test Results to Evaluate Immunity or Protection From COVID-19, Including After Vaccination

The following quote is attributed to Tim Stenzel, M.D., Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center…