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FDA issues a draft guidance on Select Updates for Guidance for the Non-Clinical and Clinical Investigation of Devices Used for the Treatment of Benign...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...
FDA publishes a guidance on modifications and revisions to an approved REMS.
Sens. Rubio and Warren introduce legislation to study the impact of foreign government investment in the U.S. drug supply chain.
FDA Review posts product approval summaries for the week ending 7/10/2020