Federal Register notice: FDA makes available guidance documents related to Covid19 that have been implemented without prior comment.
A Pennsylvania federal court orders Boehringer Ingelheim to stop using several promotional claims for its COPD medications.
National Institute of Allergy and Infectious Diseases director Anthony Fauci dismisses any notion that a reported serious adverse reaction associated ...
FDA updates FAQs on submitting adverse events reports for medical devices marketed under emergency use authorizations.
CDRH executives say they encourage and will consider innovative proposals from Covid-19 test developers.
FDA warns Nutritional Supplements Corp. that it is marketing unapproved and misbranded new drugs.
An FDA safety alert warns patients and health care providers about the risk of injury that may happen to patients if the cold-therapy mode on hot/cold...
FDA clears a Roche 510(k) for the cobas BKV Test and its use on the cobas 6800 and 8800 Systems.