FDA commissioner Robert Califf says the agency is preparing a manuscript to outline a strategy for getting more diversity into clinical trials.
FDA amends the emergency use authorizations of the updated (bivalent) Moderna and Pfizer-BioNTech Covid-19 vaccines for use in children as young as si...
FDA denies an Americans for Homeopathic Choice petition asking that some homeopathic drugs not be considered new drugs and thus not subject to premark...
FDA warns Orlando, FL-based Cryos International about significant deviations from human cell, tissue, and cellular and tissue-based products regulatio...
FDA also says it expects that many homeopathic drug products will fall outside the categories of drug products that FDA intends to prioritize for enfo...
FDA denies a petition filed by attorney James Czaban involving the regulation as medical devices of surgical scrubs for daily wear by healthcare worke...
PhRMA urges FDA to work internationally to harmonize any change in the approach to premarket safety analytics.
CDRH researchers analyze the causes of medical device shortages before and during the pandemic and call for more information from manufacturers to mit...
