News

FDA In Brief: FDA Alerts Patients and Health Care Providers About Possible Problems with Mammograms Performed at Capitol Radiology LLC

The following quote is attributed to David Lee, M.D., director, Division of Mammography Quality Standards, Office of In Vitro Diagnostics and Radiological Health, FDA’s Center…

FDA In Brief: FDA Solicits Public Feedback on Discussion Paper as Part of its Ongoing Commitment to Patient Safety

The following is attributed to Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health “The FDA continues to explore new…

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FDA In Brief: FDA Issues Draft Guidance on Early Clinical Studies for Certain Medical Devices to Improve Glycemic Control for Type 2 Diabetes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

Coronavirus (COVID-19) Update: May 18, 2021

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: On May 17, the…

FDA In Brief: Science Forum Highlights Regulatory Science Advancements in Protecting and Promoting Public Health

The following quote is attributed to FDA Chief Scientist Rear Adm. Denise Hinton “I am extremely proud of the hard work and dedication of our…

FDA In Brief: FDA Provides Guidance on Master Protocols for Evaluating Prevention, Treatment Options for COVID-19

The following quote is attributed to Janet Woodcock, M.D., Acting FDA Commissioner “During this global pandemic, the FDA worked to protect the American public by…

Coronavirus (COVID-19) Update: May 14, 2021

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: As part of the…

FDA In Brief: FDA Continues to Monitor the Effects of Magnets in Consumer Electronics on Implanted Medical Devices

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