Radiopharmaceutical regulation and food and drug administration policy

Seminars in Nuclear Medicine

Volumn 26, Issue 2, 1996, Pages 96-106

  Rotman, Mark ^a   Laven, David ^b   Levine, Geoffrey ^a  

^a NATIONAL INSTITUTES OF HEALTH   (United States)

^b Bay Pines VA Medical Center   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DIAGNOSTIC AGENT; RADIOISOTOPE;

ARTICLE; COMPUTER ASSISTED EMISSION TOMOGRAPHY; DRUG LEGISLATION; FOOD AND DRUG ADMINISTRATION; HUMAN; QUALITY CONTROL; STANDARD; UNITED STATES;

HUMANS; LEGISLATION, DRUG; QUALITY CONTROL; RADIOISOTOPES; TOMOGRAPHY, EMISSION-COMPUTED; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0030121960     PISSN: 00012998     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0001-2998(96)80031-6     Document Type: Article

References (22)

1. Rankin K: Congress Maps blueprint for New and Improved PDA. Drug Store News, November 20,1995, p 27
2. PDA: 21 CFR part 211; Current Good Manufacturing Practice for Finished Pharmaceuticals; Positron Emission Tomography. Proposed Rule. Federal Register 60(38)pl0517,1995
3. NRC: Communications Between the NRC and Licensees; Policy Statement. Federal Register 60(214)p56069, 1995
4. Clinton WJ: Presidential Documents: Regulatory Planning and Review. Executive Order 12866. Federal Register 58(190)p51735, 1993
5. Marcus CS: Regulatory Aspects of Radiopharmaceuticals: Guidelines for Developing Countries. Presented to the International Atomic Energy Agency Meeting, November 16,1992.
6. Fingl E, Woodbury DM: General Principles, in Goodman LS, Oilman A (eds): The Pharmacological Basis of Therapeutics. London, England, McMillan, 1970, p l
7. Woodbury DH: Food and Drug Administration Involvement and Approval. J Nucl Cardiol 2:62, 1995
8. CORAR: 1995 Congressional Background Paper
9. NEUROLITE: Package Insert, DuPont Pharma, 1994
10. Silberstein EB: Adverse Reactions from PositronEmitting Radiopharmaceuticals: Retrospective and Prospective Studies. J Nucl Med 36:157,1995
11. PDA: Radioactive Drugs; Revocation of Interim Enforcement Policy and Notice of Availability of a Guideline for Nuclear Pharmacies Describing Activities that Require Registration as a Drug Establishment; Notice. Federal Register 49(118)p24949,1984
12. Adams DG: Regulating PET Products as New Drugs: Legal Issues. FDA Memorandum, August 2,1989
13. FDA: 21 CFR parts 201, 208, 314, and 601: Prescription Drug Product Labelling; Medication Guide Requirements. Federal Register 60(164)p44182,1995
14. PDA: 21 CFR 820: Complete Revision to Incorporate ISO Standards: Docket No. 90N-0172,1995
15. PDA: Regulation of Positron Emission Tomography Radiopharmaceutical Drug Products; Guidance; Public Workshop Notice. Federal Register 60(38)pl0594,1995
16. Lundgren DE: Letter from Office of the Attorney General State of California to the PDA. June 1,1995
17. Lundgren DE: Letter from the Office of the Attorney General State of California to the PDA. March 2,1993
18. Catizone CA: Letter from the National Association of Boards of Pharmacy to the PDA. March 23,1995
19. Younger EJ: Legal Opinion from the Office of the Attorney General State of California, May 2,1978
20. Keesee RE: the Legal Status of Pharmacist Compounding Under the Federal Food, Drug, and Cosmetic Act. Presented at the APhA Annual Meeting, 1993
21. Syncor International Corporation: US District Court, Washington DC: Complaint for Declaratory Relief v Donna E. Shalala, David A. Kessler, August 24, 1995, Docket No. 95cv01627
22. Foster SL, Smith EB, Seybold MR: Advanced Counseling Techniques: Integrating Assessment and Intervention. Am Pharm NS35:40,1995