FDA warns Angela Stupi in Cranberry Twp., PA, about violations in her conduct of two trials with investigational drugs.
Federal Register notice: FDA announces a 10/5 Oncologic Drugs Advisory Committee meeting to discuss an Amgen supplemental NDA for Lumakras (sotorasib)...
The Consumer Healthcare Product Association tells CDRH patient self-diagnosis need not be a requirement for the at-home use of over-the-counter medica...
FDA warns Walmart and Amazon they are illegally distributing unapproved new drugs to treat molluscum contagiosum.
FDA warns Noblesville, IN-based Ambu, Inc., that it is illegally distributing an unapproved medical device.
FDA lifts a clinical hold against a Fulcrum Therapeutics IND for FTX-6058 for the potential treatment of sickle-cell disease.
Federal Register notice: FDA makes available additional draft and revised draft product-specific guidances for generic drug developers.
Metacel says FDA must require sponsors of generic Ozobax to perform and submit the same flavoring safety data that Metacel was required to submit.
