Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical Development; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical Development." This guidance is intended to assist sponsors in identifying an optimized dosage for radiopharmaceutical therapies (RPT) for oncology indications during clinical development and prior to submitting a marketing application for a new indication and usage. The guidance provides considerations for RPT dosage optimization in RPT development programs.
Abstract as published in the Federal Register.
The complete document — every provision, the docket, and the comment instructions — is published in the Federal Register. SPEQ surfaces and indexes it for reference; the authoritative text lives on federalregister.gov.
View on federalregister.gov →Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.