WASHINGTON, Aug. 19 -- Food and Drug Administration has issued a notice called: Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical Development; Draft Guidance for Industry; Availability.
The notice was published in the Federal Register on Aug. 19 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.
Summary: The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical Development."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...