> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Info Collection on Radiopharmaceuticals
- URL: https://www.fdaweb.com/info-collection-on-radiopharmaceuticals-2/
- Published: 2021-04-14T12:00:00.000Z
- Updated: 2026-09-14T16:54:56.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5149106

*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” (OMB Control Number 0910-0409). FDA regulations require manufacturers of diagnostic radiopharmaceuticals to submit information that demonstrates the safety and effectiveness of: (**1**) A new diagnostic radiopharmaceutical; or (**2**) a new indication for use of an approved diagnostic radiopharmaceutical. Information about the safety or effectiveness of a diagnostic radiopharmaceutical enables FDA to properly evaluate the safety and effectiveness profiles of such radiopharmaceuticals. The information, which is usually submitted as part of a new drug application or biologics license application or as a supplement to an approved application typically includes, but is not limited to, 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-2021-04-14/pdf/2021-07639.pdf?ref=fdaweb.com).