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# Info Collection on Radiopharmaceuticals
- URL: https://www.fdaweb.com/info-collection-on-radiopharmaceuticals/
- Published: 2024-01-24T12:00:00.000Z
- Updated: 2026-09-14T14:21:04.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5156205

*Federal Register* notice: FDA has submitted to OMB an information collection extension entitled “Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring — 21 CFR Part 315.” The collection supports agency regulations that require manufacturers of diagnostic radiopharmaceuticals to submit information that demonstrates the safety and effectiveness of a new product or a new indication. for use of an approved diagnostic radiopharmaceutical. Such information can include nonclinical and clinical data on the pharmacology; toxicology; adverse events; radiation safety assessments; and chemistry, manufacturing, and controls. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2024-01-23/pdf/2024-01237.pdf?ref=fdaweb.com).