Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring

OMB 0910-0409

OMB 0910-0409

This information collection supports agency regulations at 21 CFR 315.4, 315.5, and 315.6. The regulations require manufacturers of diagnostic radiopharmaceuticals to submit certain information demonstrating safety and effectiveness of these products.

The latest form for Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring expires 2021-05-31 and can be found here.

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