Regulatory requirements for PET drug production

Journal of Nuclear Medicine

Volumn 55, Issue 7, 2014, Pages 1132-1137

  Schwarz, Sally W ^a   Dick, David ^b   VanBrocklin, Henry F ^c   Hoffman, John M ^d,e  

^a WASHINGTON UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b UNIVERSITY OF IOWA   (United States)

^c UNIVERSITY OF CALIFORNIA   (United States)

^d UNIVERSITY OF UTAH   (United States)

^e UNIVERSITY OF UTAH SCHOOL OF MEDICINE   (United States)

Author keywords

Annual reporting; FDA inspections; FDA part 212; NDA ANDA; USP chapter 823

Indexed keywords

TRACER; RADIOPHARMACEUTICAL AGENT;

DRUG APPROVAL; DRUG CONTROL; DRUG MANUFACTURE; DRUG QUALITY; DRUG SAFETY; DRUG STABILITY; FOOD AND DRUG ADMINISTRATION; HEALTH CARE FACILITY; HUMAN; LABORATORY; MEDICAL LITERATURE; NONHUMAN; PERSONNEL MANAGEMENT; PRIORITY JOURNAL; REGISTRATION; REVIEW; DIAGNOSTIC USE; ECONOMICS; FEE; GOVERNMENT REGULATION; LEGISLATION AND JURISPRUDENCE; POSITRON EMISSION TOMOGRAPHY; QUALITY CONTROL; UNITED STATES;

DRUG APPROVAL; DRUG STABILITY; FEES AND CHARGES; GOVERNMENT REGULATION; POSITRON-EMISSION TOMOGRAPHY; QUALITY CONTROL; RADIOPHARMACEUTICALS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84904133372     PISSN: 01615505     EISSN: None     Source Type: Journal    
DOI: 10.2967/jnumed.113.132472     Document Type: Review

References (27)

1. Current good manufacturing practice for positron emission tomography drugs. Fed Regist. 2009;74:65409. To be codified at 21 CFR §210, 211, and 212.
2. Current good manufacturing practice for positron emission tomography drugs: preliminary draft proposed rule. Fed Regist. 1995;60:10594.
3. Food and Drug Modernization Act of 1997. U.S. Food and Drug Administration website. http://www.fda.gov/RegulatoryInformation/Legislation/ FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FDAMA/ FullTextofFDAMAlaw/default.htm. Updated October 22, 2009. Accessed May 8, 2014.
4. Positron emission tomography drug products; safety and effectiveness of certain PET drugs for specific indications. Fed Regist. 2000;65:12999-13010.
5. Guidance on current good manufacturing practice for positron emission tomography drugs; availability. Fed Regist. 2009;74:65538.
6. Guidance: PET Drugs - Current Good Manufacturing Practice (CGMP). Silver Spring, MD: Food and Drug Administration; 2009.
7. NDA 21-768: FDG F 18 injection. U.S. Food and Drug Administration website. http://www.accessdata.fda.gov/drugsatfda-docs/label/2004/21768lbl.pdf. Accessed May 8, 2014.
8. NDA 21-870: FDG F 18 injection. U.S. Food and Drug Administration website. http://www.accessdata.fda.gov/drugsatfda-docs/label/2005/021870lbl.pdf. Accessed May 8, 2014.
9. Drug approval package: Ammonia N 13 injection. U.S. Food and Drug Administration website. http://www.accessdata.fda.gov/drugsatfda-docs/nda/2007/ 22119s000TOC.cfm. Published October 2, 2007. Accessed May 8, 2014.
10. Cancer tracer synthesis resources. National Cancer Institute website. http://imaging.cancer.gov/programsandresources/Cancer-Tracer-Synthesis- Resources. Accessed May 8, 2014.
11. Positron emission tomography (PET): questions and answers about CGMP regulations for PET drugs. U.S. Food and Drug Administration website. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/ucm193476. htm#PETDRUGSANDUSERFEES. Published December 9, 2009. Updated February 18, 2011. Accessed May 8, 2014.
12. 2011 USP 34 NF 29. Rockville, MD: U.S. Pharmacopeial Convention; 2011.
13. Radioactive Drug Research Committee (RDRC) program. U.S. Food and Drug Administration website. http://www.fda.gov/Drugs/ScienceResearch/ResearchAreas/ Oncology/ucm093322.htm. Updated on August 29, 2013. Accessed May 8, 2014.
14. Investigational new drug (IND) application. U.S. Food and Drug Administration website. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/ HowDrugsareDevelopedandApproved/ApprovalApplications/ InvestigationalNewDrugINDApplication/default.htm. Updated on October 18, 2013. Accessed May 8, 2014.
15. Guidance: PET Drug Applications - Content and Format for NDAs and ANDAs. Silver Spring, MD: Food and Drug Administration; 2011.
16. Orange book: approved drug products with therapeutic equivalence evaluations. U.S. Food and Drug Administration website. http://www.accessdata. fda.gov/scripts/cder/ob/default.cfm. Updated May 17, 2013. Accessed May 8, 2014.
17. Positron emission tomography (PET): additional questions and answers based on December 9, 2009 stakeholder call [response to question 7]. U.S. Food and Drug Administration website. http://www.fda.gov/Drugs/ DevelopmentApprovalProcess/Manufacturing/ucm207021.htm. April 8, 2010. Accessed May 8, 2014.
18. 21 CFR 207: registration of producers of drugs and listing of drugs in commercial distribution. 207.21(a); 21 CFR 207.3(a)(8). Food and Drug Administration website. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/ CFRSearch.cfm?CFRPart=207. Accessed June 4, 2014.
19. Drug registration and listing system (DRLS & eDRLS). U.S. Food and Drug Administration website. http://www.fda.gov/Drugs/ GuidanceComplianceRegulatoryInformation/DrugRegistrationandListing/default.htm. Updated December 2, 2013. Accessed May 8, 2014.
20. Electronic drug registration and listing instructions. U.S. Food and Drug Administration website. http://www.fda.gov/Drugs/ GuidanceComplianceRegulatoryInformation/DrugRegistrationandListing/ucm078801. htm. Updated March 17, 2014. Accessed May 8, 2014.
21. Guidance for Industry: Providing Regulatory Submissions in Electronic Format - Drug Establishment Registration and Drug Listing. Rockville, MD: Food and Drug Administration; 2009.
22. Electronic submissions gateway. U.S. Food and Drug Administration website. http://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/default. htm. Updated April 25, 2014. Accessed May 9, 2014.
23. Prescription Drug User Fee Act (PDUFA). U.S. Food and Drug Administration website. http://www.fda.gov/forindustry/userfees/prescriptiondruguserfee/ default.htm. Updated May 6, 2014. Accessed May 9, 2014.
24. Generic drug user fee amendments of 2012. U.S. Food and Drug Administration website. http://www.fda.gov/ForIndustry/UserFees/ GenericDrugUserFees/default.htm. Updated May 9, 2014. Accessed May 9, 2014.
25. Guidance for Industry: CMC Postapproval Manufacturing Changes to Be Documented in Annual Reports. Silver Spring, MD: Food and Drug Administration; 2014.
26. 21 CFR 314.80: postmarketing reporting of adverse drug experiences. Food and Drug Administration website. http://www.accessdata.fda.gov/scripts/cdrh/ cfdocs/cfcfr/cfrsearch.cfm?fr=314.80. Updated June 1, 2013. Accessed May 9, 2014.
27. 21 CFR 314.81: other postmarketing reports. Food and Drug Administration website. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm? fr=314.81. Updated June 1, 2013. Accessed May 9, 2014.