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...
FDA issues a final guidance describing CDERs program for the recognition of voluntary consensus standards related to drug quality.
FDA approves an Octapharma NDA for Balfaxar (prothrombin complex concentrate) for the urgent reversal of acquired coagulation factor deficiency induce...
