House GOP leadership delay a floor vote on FDAs fiscal year 2024 budget bill until lawmakers return from their August recess.
FDA clears a Shenzhen Superbio 510(k) for a point-of-care instrument intended for the qualitative detection of fentanyl in human urine.
Federal Register notice: FDA announces a 9/27 Cellular, Tissue, and Gene Therapies Advisory Committee meeting to discuss a BrainStorm Therapeutics sup...
Federal Register notice: FDA permanently debars Diana Daffin from providing services in any capacity to a person that has an approved or pending drug ...
Attorney Tim Philips outlines best- and worst-case scenarios in the coming ORA reorganization.
Sun Pharma asks FDA to seek recalls of unapproved phenobarbitol products and notify healthcare providers and consumers of the dangers of those product...
FDA releases the form FDA-483 with six observations from an inspection at Allentown, PA-based Central Admixture Pharmacy Services.
Three Sheppard Mullin attorneys say FDA appears to be focusing on medical device enforcement of device-associated software that is promoted for uses b...
