Revocation of Regulation on Positron Emission Tomography Drug Products
other · Food and Drug Administration · Rule · Published 1997-12-19 · Effective 1997-12-21 · 62 FR 66522
Document
Document number
97-33187
Federal Register citation
62 FR 66522
CFR reference
21 CFR 211
Type
Rule
Action
Final rule; revocation.
Category
other
Sub-agency
Food and Drug Administration
Publication date
1997-12-19
Effective date
1997-12-21
HHS docket
Docket No. 94N-0421
Abstract
The Food and Drug Administration (FDA) is revoking a regulation on positron emission tomography (PET) radiopharmaceutical drug products. The regulation permits FDA to approve requests from manufacturers of PET drugs for exceptions or alternatives to provisions of the current good manufacturing practice (CGMP) regulations. FDA is taking this action in accordance with provisions of the Food and Drug Administration Modernization Act of 1997 (Modernization Act). Elsewhere in this issue of the Federal Register, FDA is publishing a notice revoking two notices concerning certain guidance documents on PET drugs and the guidance documents to which the notices relate.