Food and Drug Administration Requirements for Testing and Approval of New Radiopharmaceuticals

References 

1. Draft Guidance for Industry and Review Staff: Target product profile—A strategic development process Tool. March 2007;
2. Draft Guidance for Industry Format and Content of Proposed Risk Evaluation and Mitigation: Strategies (REMS), REMS assessments, and proposed REMS modifications. Sept 2009;
3. Guidance for Industry: Development and Use of Risk Minimization Action Plans. March 2005;
4. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use: ICH Harmonized Tripartite Guideline on Pharmaceutical. Development Q8 R2. 2009;
5. Guidance on PET Drugs: Current Good Manufacturing Practice (CGMP). December 2009;
6. Draft Guidance for Industry and Researchers: The Radioactive Drug Research Committee: Human research without An investigational New Drug Application. June 2009;
7. Guidance for Industry, Investigators and Reviewers: Exploratory IND Studies. January 2006;
8. “Guidance for Industry—Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-derived Products”
9. Fed Regist. 2004;69:17927
10. Developing medical imaging drug and biological products. Part 1: Conducting safety assessments. Part 2: Clinical Indications. Part 3: Design, Analysis and Interpretation of Clinical Studies. June 2004;
11. Draft Guidance for Industry: Applications Covered by Section 505(b)(2). October, 1999;
12. US Department of Health and Human Services, Food and Drug Administration. Prescription Drug User Fee Act. http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/default.htmAccessed May 12, 2010
13. Department of Health and Human Services, Food and Drug Administration. Positron Emission Tomography (PET): Questions and Answers about CGMP Regulations for PET Drugs. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/ucm193476.htmAccessed May 12, 2010
14. Positron Emission Tomography (PET): Products, safety and effectiveness of certain PET drugs for specific indications. Fed Regist. 2000;65:12999–13010
15. Draft Guidance on the Content and Format of NDAs/ANDAs for Certain Pet Drug Products FDG: F-18 injection, ammonia N 13 injection, and sodium fluoride F-18 injection. Fed Regist. 2000;65:13010–13012
16. Guidance for Industry M4: Organization of the CTD. August 2001;
17. Guidance for Industry M2 eCTD: Electronic Common Technical Document Specification. April 2003;
18. Guidance for FDA Advisory Committee Members and FDA Staff: Voting Procedures for Advisory Committee Meetings. August 2008;
19. Guidance for Industry: CGMP for Phase 1 Investigational Drugs. July 2008;
20. Guidance on PET Drugs—Current Good Manufacturing Practice. December 2009;
21. Harapanhalli RS: Bench to bedside—the roadmap, in CMC Issues in Radiopharmaceutical Applications, Society of Nuclear Medicine Annual Meeting, Louisiana, New Orleans June 18-21, 2008
22. Guidance for FDA Staff and Industry, Compliance Policy Guides Manual Section 460.200: Pharmacy Compounding. May 2002;
23. Guidance for Industry, Providing Regulatory Submissions in Electronic Format-Drug Establishment Registration and Drug Listing. May 2009;