NCCN Oncology Risk Evaluation and Mitigation Strategies White Paper: Recommendations for Stakeholders

JNCCN Journal of the National Comprehensive Cancer Network

Volumn 8, Issue SUPPL. 7, 2010, Pages

  Johnson, Philip E ^a   Dahlman, George ^a   Eng, Kirby ^a   Garg, Rekha ^a   Gottlieb, Scott ^a   Hoffman, James M ^a   Howell, Peyton ^a   Jahanzeb, Mohammad ^a   Johnson, Shirley ^a   Mackler, Emily ^a   Rubino, Mark ^a   Sarokhan, Brenda ^a   Stewart, F Marc ^a   Tyler, Tim ^a   Vose, Julie M ^a   Weinstein, Sharon ^a   Li, Edward C ^a   DeMartino, Jessica ^a  

^a NONE

Author keywords

Oncology; REMS; Risk; Safety

Indexed keywords

ALVIMOPAN; AMBRISENTAN; BOSENTAN; BUPRENORPHINE; CLOZAPINE; ECULIZUMAB; ELTROMBOPAG; FENTANYL; HYDROMORPHONE; LENALIDOMIDE; NOVEL ERYTHROPOIESIS STIMULATING PROTEIN; OLANZAPINE; OXYCODONE; RECOMBINANT ERYTHROPOIETIN; ROMIPLOSTIM; THALIDOMIDE; VIGABATRIN;

ACCESS TO INFORMATION; CANCER PATIENT; DRUG INDUSTRY; DRUG SAFETY; DRUG USE; FOOD AND DRUG ADMINISTRATION; HEALTH CARE ACCESS; HEALTH CARE POLICY; HEALTH CARE QUALITY; HEMATOLOGIC DISEASE; HUMAN; MEDICAL INFORMATION; PATIENT CARE; REVIEW; RISK FACTOR;

ADVISORY COMMITTEES; ANTINEOPLASTIC AGENTS; BIOLOGICAL PRODUCTS; DRUG INDUSTRY; DRUG LABELING; DRUG MONITORING; DRUG THERAPY; DRUG TOXICITY; DRUGS, INVESTIGATIONAL; EXPERT TESTIMONY; HEALTH CARE SURVEYS; HEALTH LITERACY; HEALTH PERSONNEL; HUMANS; INTERDISCIPLINARY COMMUNICATION; MEDICAL ONCOLOGY; OFF-LABEL USE; REIMBURSEMENT MECHANISMS; RISK ASSESSMENT; SAFETY MANAGEMENT; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 77958158869     PISSN: 15401405     EISSN: 15401413     Source Type: Journal    
DOI: None     Document Type: Review

References (8)

1. U.S. Food and Drug Administration. Guidance for Industry: Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications. Available at: http://www.fda.gov/ downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM184128.pdf. Accessed January 4, 2010.
2. Identification of drug and biological products deemed to have risk evaluation and mitigation strategies for purposes of the Food and Drug Administration Amendments Act of 2007. Washington, DC: U.S. Department of Health and Human Services. Fed Regist 2008;73(60):16313-16314-
3. U.S. Food and Drug Administration. Opioid Drugs and Risk Evaluation and Mitigation Strategies (REMS). Available at: http://www.fda.gov/Drugs/DrugSafety/ InformationbyDrugClass/ucm163647.htm. Accessed January 5, 2010.
4. U.S. Food and Drug Administration. Risk Evaluation and Mitigation Strategies for Certain Opioid Drugs; Notice of Public Meeting; Reopening of Comment Period. Washington, DC: U.S. Department of Health and Human Services. Fed Regist 2009;74:53509-53510.
5. Food and Drug Administration Amendments Act of 2007. Pub L No. 110-85, 21 USC 301 Stat 930. Available at: http://frwebgate.access.gpo.gov/cgi-bin/getdoc. cgi?dbname=110-cong-public-laws&docid=f:publ085.110. Accessed August 10, 2010.
6. Enzi MB, Kennedy EM. Risk management and intrusions on medical practice: striking a balance. Health Aff (Millwood) 2007;26:678-680.
7. Weingart SN, Brown E, Bach PB. NCCN Task Force Report: Oral Chemotherapy. J Natl Compr Canc Netw 2008;6(Suppl 3):S1-14
8. U.S. Food and Drug Administration. Approved Risk Evaluation and Mitigation Strategies (REMS). Available ac http://www.fda.gov/Drugs/DrugSafety/ PostmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm. Accessed June 1, 2010.