November 13, 2017
On Monday November 13th, SNMMI submitted comments to FDA on its draft guidance for microdose radiopharmaceutical diagnostic drugs. FDA released the draft document in September and intends for the guidance to assist sponsors of microdose radiopharmaceutical diagnostic drugs on the nonclinical studies recommended to support human clinical trials and marketing applications.
The guidance addresses FDA’s current thinking regarding regulation of this class of drugs and provides complementary recommendations to the guidance for industry, investigators, and reviewers. The guidance discusses how to refine nonclinical study recommendations for this class of drug given its unique characteristics (e.g., microdose, radiolabeled, single or infrequent), use, clinical use setting, and the Agency’s nonclinical and clinical safety experience with these drugs.
SNMMI commends the FDA on the release of this guidance and believes it will help illuminate a clear pathway to full drug development (marketing authorization) for microdose radiopharmaceutical diagnostic drugs. The draft guidance has the potential to provide valuable information and guidance for technical and physical requirements that are applicable to microdose radiopharmaceutical diagnostic drugs.