Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring
other · Food and Drug Administration · Rule · Published 1999-05-17 · Effective 1999-07-16 · 64 FR 26657
Document
Document number
99-12320
Federal Register citation
64 FR 26657
CFR reference
21 CFR 315
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
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).