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.
South Carolina GOP Rep. Jeff Duncan says FDA should retain the Office of Dietary Supplement Programs as a freestanding entity rather than merging it i...
