Sens. Warren and Smith ask FDA for information on what it needs to adequately conduct foreign drug inspections during the pandemic.
Federal Register notice: FDA makes available a revised final guidance on Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017....
Federal Register notice: FDA makes available a final guidance entitled Regulatory Considerations for Microneedling Products.
Federal Register notice: FDA makes available a final guidance entitled Enhancing the Diversity of Clinical Trial Populations Eligibility Criteria, En...
Supernus Pharmaceuticals says it has received a complete response letter and refusal to file letter from FDA for two NDAs and will seek agency guidanc...
CDER Office of Prescription Drug Promotion acting director Catherine Gray says that beginning next year the Office is revising its core launch review ...
FDA says the Stryker Neurovascular recall of its Trevo XP ProVue Retriever due to a core wire that may break or separate during use is Class 1.
CDER researchers say it may be possible to streamline clinical trials for drugs to treat schizophrenia by cutting the trial length and cutting the num...