Federal Register notice: FDA seeks comments on an information collection revision entitled Expanded Access to Investigational Drugs for Treatment Use....
Pfizer says new data on its Covid-19 oral antiviral drug Paxlovid (nirmatrelvir tablets and ritonavir tablets) show the drug significantly reduced the...
FDA warns Houstons Cooper Institute for Advanced Reproductive Medicine about significant deviations from the regulations for human cells, tissues, and...
FDA issues a guidance modifying REMS requirements for Genentechs Actemra under certain conditions during the Covid-19-related Actemra shortage.
FDA approves two Svelte Medical drug-eluting stent systems.
Federal Register notice: FDA makes available a draft guidance entitled Bowel Cleansing for Colonoscopy: Efficacy and Safety Considerations for Develop...
Federal Register notice: FDA makes available a final guidance entitled Development of Anti-Infective Drug Products for the Pediatric Population.
Federal Register notice: FDA makes available a final guidance for industry entitled Q3C (R8) Impurities: Guidance for Residual Solvents.