FDA Finalizes Guidance on Microdose Radiopharmaceutical Diagnostic Drugs

Sponsors conducting nonclinical radiopharmaceutical diagnostic drug trials can seek waivers for specific nonclinical pharmacology or toxicology studies, according to final guidance from the FDA.

The sponsors should tailor the amount and type of nonclinical supporting data to take account of low adverse event potential, the agency said.

The guidance, which finalizes the agency’s August 2017 draft with no major changes, makes specific recommendations for various study types. For example, pre-phase 1 pharmacology studies should be sufficiently sensitive to ensure pharmacologic effects at the predicted clinical dose are ruled out.