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Federal Register notice: FDA makes available a final guidance entitled CDERs Program for the Recognition of Voluntary Consensus St...[ Price : $8.95]
FDA clears a Shenzhen Superbio 510(k) for a point-of-care instrument intended for the qualitative detection of fentanyl in human u...[ Price : $8.95]
Federal Register notice: FDA announces a 9/27 Cellular, Tissue, and Gene Therapies Advisory Committee meeting to discuss a BrainSt...[ Price : $8.95]
Federal Register notice: FDA permanently debars Diana Daffin from providing services in any capacity to a person that has an appro...[ Price : $8.95]
Attorney Tim Philips outlines best- and worst-case scenarios in the coming ORA reorganization.[ Price : $8.95]
Sun Pharma asks FDA to seek recalls of unapproved phenobarbitol products and notify healthcare providers and consumers of the dang...[ Price : $8.95]
FDA releases the form FDA-483 with six observations from an inspection at Allentown, PA-based Central Admixture Pharmacy Services.[ Price : $8.95]
Three Sheppard Mullin attorneys say FDA appears to be focusing on medical device enforcement of device-associated software that is...