Journal article
Regulatory Requirements for PET Drug Production
The Journal of nuclear medicine (1978), Vol.55(7), pp.1132-1137
07/01/2014
DOI: 10.2967/jnumed.113.132472
PMID: 24914057
Abstract
The Food and Drug Administration (FDA) issued the-final rule for title 21 of Code of Federal Regulations part 212 regarding the regulations on current good manufacturing practice for PET drugs. The regulations are intended to ensure that PET drugs meet the safety and quality assurance requirements of the Federal Food, Drug, and Cosmetic Act. The new regulation became effective December 12, 2011, but the FDA used regulatory discretion to allow new drug applications and abbreviated new drug applications to be filed until June 12, 2012, without interruption of the existing PET drug production for human use. The production of PET drugs for both clinical use and clinical research use are outlined in this continuing education module, including an overview of specific requirements for compliance. Additionally, FDA preapproval inspections and postapproval reporting requirements are reviewed.
Details
- Title: Subtitle
- Regulatory Requirements for PET Drug Production
- Creators
- Sally W. Schwarz - Washington University in St. LouisDavid Dick - University of IowaHenry F. VanBrocklin - University of California, San FranciscoJohn M. Hoffman - Huntsman Cancer Institute
- Resource Type
- Journal article
- Publication Details
- The Journal of nuclear medicine (1978), Vol.55(7), pp.1132-1137
- DOI
- 10.2967/jnumed.113.132472
- PMID
- 24914057
- NLM abbreviation
- J Nucl Med
- ISSN
- 0161-5505
- eISSN
- 1535-5667
- Publisher
- Soc Nuclear Medicine Inc
- Number of pages
- 6
- Language
- English
- Date published
- 07/01/2014
- Academic Unit
- Radiology; Pharmaceutical Sciences and Experimental Therapeutics
- Record Identifier
- 9984318699702771
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