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HHS/FDA | RIN: 0910-AC55 | Publication ID: Spring 2003 |
Title: ●Positron Emission Tomography Drugs; Current Good Manufacturing Practices | |
Abstract: Section 121 of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115) directs FDA to establish requirements for current good manufacturing practices (CGMPs) for positron emission tomography (PET) drugs, a type of radiopharmaceutical. The proposed rule would adopt CGMPs that reflect the unique characteristics of PET drugs. | |
Agency: Department of Health and Human Services(HHS) | Priority: Other Significant |
RIN Status: First time published in the Unified Agenda | Agenda Stage of Rulemaking: Proposed Rule Stage |
Major: Undetermined | Unfunded Mandates: Undetermined |
CFR Citation: 21 CFR 220 | |
Legal Authority: PL 105-115, sec 121 |
Legal Deadline:
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Timetable:
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Regulatory Flexibility Analysis Required: Undetermined | Government Levels Affected: Undetermined |
Federalism: Undetermined | |
Included in the Regulatory Plan: No | |
Related RINs: Previously reported as 0910-AB63 | |
Agency Contact: Wayne H. Mitchell Regulatory Counsel, Office of Regulatory Policy Department of Health and Human Services Food and Drug Administration Suite 3037 (HFD-7), Center for Drug Evaluation and Research, 5600 Fishers Lane, HFD-7, Rockville, MD 20857 Phone:301 594-2041 Fax:301 827-0951 Email: wayne.mitchell@fda.hhs.gov |