Gilead asks FDA to rescind its orphan drug designation of the companys remdesivir as a potential treatment for Covid-19.
FDA warns California IVF Fertility Clinic about significant deviations from HCT/Ps regulations.
FDA issues an immediately-in-effect guidance: Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease-2019 (COVID-19) Public ...
Moderna tells the SEC its clinical trial of a potential Covid-19 vaccine is proceeding according to protocol and could be offered to healthcare worker...
Alston Bird attorneys say the drug industry must be prepared for FDA to creatively use existing authorities instead of physical inspections to ensure ...
Bristol Myers Squibb says it will not initiate any new clinical trials globally before 4/13 due to coronavirus concerns.
Federal Register notice: FDA cancels a 4/14 public meeting entitled International Cooperation on Cosmetics Regulation Preparation for ICCR-14 Meeting...
FDA says it will fund projects to help it better understand using real-world data to generate real-world evidence.