The U.S. Food and Drug Administration (FDA) is alerting the public that serious cases of neural tube birth defects involving the brain, spine, and spinal cord […]

The U.S. Food and Drug Administration today revised the emergency use authorization (EUA) for REGEN-COV (casirivimab and imdevimab, administered together) authorizing REGEN-COV for emergency use as […]

A change to the law will impact compounding of certain products beginning on March 23, 2020. On that date, biological products that were approved under the […]

The U.S. Food and Drug Administration today revised the emergency use authorization (EUA) for bamlanivimab and etesevimab, administered together, to include emergency use as post-exposure prophylaxis (prevention) […]

Spanish version Update [6/29/2020] FDA is alerting consumers of Saniderm Products and UVT Inc.’s voluntary recall of Saniderm Advanced Hand Sanitizer. Following FDA’s recommendation, two distributors – […]

FDA authorized Paxlovid (nirmatrelvir and ritonavir) in December 2021 for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older […]

The following home preparation instructions for doxycycline, prepared by the CDC, are not to be used except in the case of a declared public health emergency. […]

Akeega (niraparib and abiraterone acetate) Zejula (niraparib) Haemorrhage FDA is evaluating the need for regulatory action. Certain amphetamine aspartate, amphetamine sulfate, dextroamphetamine saccharate and dextroamphetamine sulfate […]

Regulatory science at FDA is the science of developing new tools, standards, and approaches to assess the safety and performance of the products it regulates. CDER’s […]