Federal Register notice: FDA makes available a final guidance entitled Cancer Clinical Trial Eligibility Criteria: Brain Metastases.
FDA issues a draft guidance on Select Updates for Guidance for the Non-Clinical and Clinical Investigation of Devices Used for the Treatment of Benign...
Federal Register notice. FDA makes available a final guidance entitled Cancer Clinical Trial Eligibility Criteria: Minimum Age Considerations for Incl...
FDA posts a drug safety-related labeling change for Eli Lilly and Incytes NDA for rheumatoid arthritis drug Olumiant to warn about hypersensitivity re...
FDA reviewers raise safety concerns on a GlaxoSmithKline BLA for belantamab mafodotin which heads to an Oncologic Drugs Advisory Committee meeting 7/1...
Sens. Rubio and Warren introduce legislation to study the impact of foreign government investment in the U.S. drug supply chain.
FDA publishes a guidance on modifications and revisions to an approved REMS.
FDA Review posts product approval summaries for the week ending 7/10/2020