Cancer Clinical Trial Eligibility Criteria: Available Therapy in Non-Curative Settings
July 27, 2022
This guidance provides recommendations to clinical investigators and sponsors regarding the inclusion of patients who have not received available therapy (commonly referred to as existing treatment options) for their cancer in clinical trials of drugs and biological products for the treatment of cancer in the non-curative setting (i.e., when there is no potential for cure or prolonged/near normal survival). For the purpose of this guidance, non-curative is generally defined as 1) unresectable, locally advanced, or metastatic disease in solid tumors or 2) hematologic malignancies with unfavorable long-term overall survival.
Providing Regulatory Submissions in Alternate Electronic Format Guidance for Industry
Final Guidance June 2022 This guidance provides recommendations on an alternate electronic format for submissions covered under an exemption from or a waiver of the requirements of section 745A(a) of...