# Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring
> **Food and Drug Administration** · Final rule. · Published 1999-05-17 · Effective 1999-07-16 · 64 FR 26657
## Document
- **Document number:** 99-12320
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 64 FR 26657
- **CFR reference:** 21 CFR 315
- **Publication date:** 1999-05-17
- **Effective date:** 1999-07-16
- **HHS docket:** Docket No. 98N-0040
## Abstract

The Food and Drug Administration (FDA) is issuing regulations on the evaluation and approval of in vivo radiopharmaceuticals used in the diagnosis and monitoring of diseases. FDA is issuing these regulations in accordance with the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). These regulations are intended to clarify existing regulations applicable to the approval of radiopharmaceutical drugs and biologics under the Federal Food, Drug, and Cosmetic Act (the act) and the Public Health Service Act (the PHS Act).

## Source
- [Federal Register document](https://www.federalregister.gov/documents/1999/05/17/99-12320/regulations-for-in-vivo-radiopharmaceuticals-used-for-diagnosis-and-monitoring)
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