FDA publishes a proposed rule to make the investigational new drug annual reports more comprehensive and similar to those in other countries.
FDA publishes a draft guidance on the content of human factor and usability engineering information to be included in medical device marketing submiss...
Two stakeholder associations comment on an FDA draft guidance on general clinical pharmacology considerations for pediatric studies of drugs.
Dewei Medical Equipment recalls its DNA/RNA Preservation Kits because the products were distributed to U.S. customers without FDA authorization, clear...
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...
