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FDA warns Mexicos Nartex Laboratories about CGMP violations in its production of finished drugs.[ Price : $8.95]
Amgen and AstraZeneca say their investigational asthma drug tezepelumab achieved positive results in the Phase 3 NAVIGATOR trial.[ Price : $8.95]
Sens. Warren and Smith ask FDA for information on what it needs to adequately conduct foreign drug inspections during the pandemic...[ Price : $8.95]
Federal Register notice: FDA makes available a revised final guidance on Assessing User Fees Under the Prescription Drug User Fee ...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Regulatory Considerations for Microneedling Products.[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Enhancing the Diversity of Clinical Trial Populations Elig...[ Price : $8.95]
Supernus Pharmaceuticals says it has received a complete response letter and refusal to file letter from FDA for two NDAs and will...[ Price : $8.95]
CDER Office of Prescription Drug Promotion acting director Catherine Gray says that beginning next year the Office is revising its...