Managing risk in developing transplant immunosuppressive agents: The new regulatory environment

American Journal of Transplantation

Volumn 11, Issue 9, 2011, Pages 1803-1809

  Gabardi, S ^a   Halloran, P F ^b   Friedewald, J ^c  

^a BRIGHAM AND WOMEN S HOSPITAL   (United States)

^b UNIVERSITY OF ALBERTA   (Canada)

^c NORTHWESTERN UNIVERSITY   (United States)

Author keywords

Drug safety; immunosuppressants; immunosuppression; organ transplantation; risk evaluation and mitigation strategies

Indexed keywords

AZATHIOPRINE; BELATACEPT; CALCINEURIN INHIBITOR; CYCLOSPORIN; ECULIZUMAB; EVEROLIMUS; MAMMALIAN TARGET OF RAPAMYCIN INHIBITOR; MYCOPHENOLIC ACID; MYCOPHENOLIC ACID 2 MORPHOLINOETHYL ESTER; RAPAMYCIN;

ARTICLE; CLINICAL PRACTICE; CONGENITAL MALFORMATION; DRUG APPROVAL; DRUG LEGISLATION; DRUG MONITORING; DRUG RESEARCH; DRUG SAFETY; EDEMA; FOOD AND DRUG ADMINISTRATION; GRAFT THROMBOSIS; HEALTH CARE ORGANIZATION; HEALTH CARE PERSONNEL; HEMOLYTIC UREMIC SYNDROME; HUMAN; HYPERLIPIDEMIA; IMMUNOSUPPRESSIVE TREATMENT; INFECTION; LYMPHOPROLIFERATIVE DISEASE; MENINGOCOCCOSIS; NEOPLASM; NEPHROTOXICITY; OUTCOME ASSESSMENT; PAROXYSMAL NOCTURNAL HEMOGLOBINURIA; PATIENT EDUCATION; PATIENT INFORMATION; POSTMARKETING COMMITMENT; POSTMARKETING REQUIREMENT; PRIORITY JOURNAL; PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY; PROTEINURIA; RISK BENEFIT ANALYSIS; RISK EVALUATION AND MITIGATION STRATEGY; THERAPEUTIC MISCONCEPTION; THROMBOSIS; TRANSPLANTATION; WOUND HEALING IMPAIRMENT;

DRUG APPROVAL; IMMUNOSUPPRESSIVE AGENTS; PRODUCT SURVEILLANCE, POSTMARKETING; RISK; TRANSPLANTATION; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 80052261503     PISSN: 16006135     EISSN: 16006143     Source Type: Journal    
DOI: 10.1111/j.1600-6143.2011.03653.x     Document Type: Article

References (24)

1. Baciu A, Stratton K, Burke SP,. The future of drug safety: Promoting and protecting the health of the public. Washington, DC: National Academies Press, 2006.
2. Psaty BM, Kom D,. Congress responds to the IOM drug safety report: In full. JAMA 2007; 298: 2185-2187. (Pubitemid 350106657)
3. Food and Drug Administration Ammendments of 2007, Pub. L. 2007.
4. FDA Guidance for Industry: Development and Use of Risk Minimization Action Plans. 2005.
5. Food and Drug Administration Guidance for Industry: Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications. 2009.
6. Approved Risk Evaluation and Mitigations Strategies (REMS). US Food and Drug Administration 2011. Available at:. Accessed May 18, 2011.
7. Identification of drug and biological products deemed to have risk evaluation and mitigation strategies for purposes of the Food and Drug Administration Act of 2007. In: Federal Register, Vol 73, p. 16313, 2008.
8. NDA 21-560 ZORTRESS® (everolimus). US Food and Drug Administration 2010. Available at:. Accessed May 18, 2011.
9. NDA 21-083, NDA 21-110 RAPAMUNE® (sirolimus). US Food and Drug Administration 2010. Available at:. Accessed May 18, 2011.
10. Risk Evaluation and Mitigation Strategy (REMS) Under Review for CellCept and Myfortic. US Food and Drug Administration 2009. Available at:. Accessed May 18, 2011.
11. Stegall MD, Gloor JM,. Deciphering antibody-mediated rejection: New insights into mechanisms and treatment. Curr Opin Organ Transplant 2010; 15: 8-10.
12. Kavanagh D, Richards A, Goodship T, Jalanko H,. Transplantation in atypical hemolytic uremic syndrome. Semin Thromb Hemost 2010; 36: 653-659.
13. BLA 125166 Soliris® (eculizumab). US Food and Drug Administration 2010. Available at:. Accessed May 18, 2011.
14. Vincenti F,. Costimulation blockade: What will the future bring? Nephrol Dial Transplant 2007; 22: 1293-1296. (Pubitemid 47072213)
15. Briefing Document for March 2010 Meeting: Belatacept (BMS-224818). FDA's Cardiovascular and Renal Drugs Advisory Committee 2010. Available at:. Accessed May 18, 2011.
16. 21 Code of Federal Regulations 314.510 and 601.41(Accelerated Approval).
17. 21 Code of Federal Regulations 314.55 and 601.27(b) (PREA).
18. 21 Code of Federal Regulations 314.60(b)(1) (Animal Efficacy Rule).
19. FDA Center for Drug Evaluation and Research. Procedures and Responsibilities for Developing Postmarketing Requirements and Commitments: Manual of Policies and Procedures (MAPP) 6010.9. 2009.
20. Application Number 21-560: Summary Review. Center for Drug Evaluation and Research 2011. Available at:. Accessed May 18, 2011.
21. Adverse Event Reporting System (AERS). US Food and Drug Administration 2010. Available at:. Accessed May 18, 2011.
22. FDA's Sentinel Initiative. US Food and Drug Administration 2011. Available at:. Accessed May 18, 2011.
23. Observational Medical Outcomes Partnership. Foundation for the National Institutes of Health 2011. Available at:. Accessed May 18, 2011.
24. McCaughan M,. The risk of risk management. Regulation Policy Market Report 2007. Available at:. Accessed May 18, 2011.