Articles by U.S. Food and Drug Administration

Global regulators envision paradigm shift toward inclusion of pregnant and breastfeeding women in clinical research

The US is experiencing significant interruptions in the supply of sodium citrate blood specimen collection tubes

New drug approved to help fight the variola virus should the virus be weaponized

Currently authorized SARS-CoV-2 antibody tests should not be used to evaluate immunity after COVID-19 vaccination

FDA: the potential benefits of the vaccine in those 12 years of age and older outweigh the known and potential risks

The agency determined that the criteria for issuance of an authorization are no longer met and has revoked the EUA

New implant device provides option to treat pulmonary valve regurgitation in patients with right ventricular outflow tract

This is the first SARS-CoV-2 diagnostic test permitted to be marketed beyond the public health emergency

If mutations occur in the part of the virus’s genome assessed by a test, the mutations can cause false negative results

FDA provides more regulatory relief during outbreak, continues to help expedite availability of diagnostics