💊FDA Draft Guidance on Oncology Radiopharmaceuticals Dosage Optimization
Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical Development; Draft Guidance for Industry; Availability
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The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical Development."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 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.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The draft guidance relates to dosage optimization for oncology therapeutic radiopharmaceuticals, directly impacting compliance and regulatory requirements for businesses in the pharmaceutical and healthcare sectors. Businesses involved in RPT development must adapt to new guidelines potentially affecting their marketing applications and safety protocols.