Introduction to College on Problems of Drug Dependence special conference on risk management and post-marketing surveillance of CNS drugs

Drug and Alcohol Dependence

Volumn 105, Issue SUPPL. 1, 2009, Pages

  Schuster, Charles R ^a,b   Barthwell, Andrea G ^c   Henningfield, Jack E ^d,e  

^a CRS Associates LLC   (United States)

^b WAYNE STATE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c EMGlobal LLC   (United States)

^d JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^e PINNEY ASSOCIATES   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CENTRAL NERVOUS SYSTEM AGENTS;

ADDICTION; DRUG CONTROL; EDITORIAL; HUMAN; LEGAL ASPECT; POSTMARKETING SURVEILLANCE; RISK MANAGEMENT;

CENTRAL NERVOUS SYSTEM AGENTS; DRUG AND NARCOTIC CONTROL; HUMANS; PRODUCT SURVEILLANCE, POSTMARKETING; RISK MANAGEMENT; SUBSTANCE-RELATED DISORDERS;

EID: 73949152551     PISSN: 03768716     EISSN: 18790046     Source Type: Journal    
DOI: 10.1016/j.drugalcdep.2009.08.005     Document Type: Editorial

References (40)

1. Ator N.A., Griffiths R.R. Principles of experimental drug abuse liability assessment in laboratory animals. Drug Alcohol Depend. 2003, 70(Suppl. 3):S55-S72.
2. Balster R.L., Bigelow G.E. Guidelines and methodological reviews concerning drug abuse liability assessment. Drug Alcohol Depend. 2003, 70(Suppl. 3):S13-S40.
3. Carter L.P., Griffiths R.R. Principles of laboratory assessment of drug abuse liability and implications for clinical development. Drug Alcohol Depend. 2009, 105(Suppl. 1):S14-S25.
4. Covance, 2005. iPLEDGE: committed to pregnancy prevention. Available at: (accessed on March 25, 2009). https://www.ipledgeprogram.com/.
5. Dart R.C. Monitoring risk: post marketing surveillance and signal detection. Drug Alcohol Depend. 2009, 105(Suppl. 1):S26-S32.
6. Dasgupta N., Schnoll S.H. Signal detection in post-marketing surveillance for controlled substances. Drug Alcohol Depend. 2009, 105(Suppl. 1):S33-S41.
7. Drug Enforcement Administration, 2009. Title 21 - Food and Drugs Chapter 13 - Drug Abuse and Prevention and Control. Available at: (accessed on August 8, 2009). http://www.deadiversion.usdoj.gov/21cfr/21usc/index.html.
8. European Medicines Agency, 2005. Post-authorization evaluation of medicines for human use: guidelines for risk management systems for medicinal products for human use. Available at: (accessed August 7, 2009). http://www.invima.gov.co/Invima/BVSalud/IVC/anexo5emeagrmsmp.pdf.
9. Fetterman J.E., Nickel W.K., Pines W.L., Slatko G.H. A Framework for Pharmaceutical Risk Management 2003, Food and Drug Law Institute, Washington, DC.
10. Food and Drug Administration, 2005a. A synopsis of the elements of the S.T.E.P.S.® Program. Available at: (accessed on June 10, 2009). http://www.fda.gov/ohrms/dockets/ac/04/briefing/4017B1-06b%2520Overview%2520STEPS%2520Section%2520C%2520Tab%25207.htm.
11. Food and Drug Administration, 2005b. Guidance for industry: premarketing risk assessment. Available at: (accessed on August 8, 2009). http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm126958.pdf.
12. Food and Drug Administration, 2005c. Guidance for industry: development and use of risk minimization action plans. Available at: (accessed on August 8, 2009). http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126830.pdf.
13. Food and Drug Administration, 2005d. Guidance for the industry: good pharmacovigilance practices and pharmacoepidemiologic assessment. Available at: (accessed on August 20, 2009). http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126834.pdf.
14. Food and Drug Administration, 2007. Food and Drug Administration Amendments Act of 2007. Congressional Record, 2007. Pub. L. No. 110-85, § 505-1.
15. Food and Drug Administration, 2008a. Information for healthcare professionals: suicidal behavior and ideation and antiepileptic drugs. Available at: (accessed on May 27, 2009). http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm100192.htm.
16. Food and Drug Administration, March, 2008b. 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. Federal Register 73(60), 16313-16314. Available at: (accessed June 10, 2009). http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-6201.pdf.
17. Food and Drug Administration, 2009a. Proposed opioid REMS, presentation by Sharon Herz, FDA. (accessed on June 10, 2009). http://www.fda.gov/downloads/Drugs/DrugSafety/InformationbyDrugClass/UCM163675.pdf.
18. Food and Drug Administration, February, 2009b. Transcript for FDA's media briefing on the safe use of opioids. Available at: (accessed August 8, 2009). http://www.fda.gov/downloads/NewsEvents/Newsroom/MediaTranscripts/UCM166237.pdf.
19. Food and Drug Administration 2009c. Opioid drugs and Risk Evaluation Mitigation Strategies (REMS): FDA to meet with drug companies about REMS for certain opioid drugs. Available at: (accessed on March 26, 2009). http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm163647.htm.
20. Food and Drug Administration, 2009d. Risk Evaluation and Mitigation Strategies for certain opioid drugs; Notice of public meeting. Federal Register, 74, 17967-19970. Available at: (accessed June 10, 2009). http://www.fda.gov/OHRMS/DOCKETS/98fr/E9-8992.htm.
21. Griffiths R.R., Bigelow G.E., Ator N.A. Principles of experimental drug abuse liability assessment in humans. Drug Alcohol Depend. 2003, 70(Suppl. 3):S41-S54.
22. Grudzinskas C., Balster R.L., Gorodetzky C.W., Griffiths R.R., Henningfield J.E., Johanson C.-E., Mansbach R.S., McCormick C.G., Schnoll S.H., Wright C. Impact of formulation on the abuse liability, safety, and regulation of medications: the expert panel report. Drug Alcohol Depend. 2006, 83(Suppl. 1):S77-S82.
23. Health Canada, 2009. Questions and answers regarding the implementation of risk management planning (accessed August 7, 2009). http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/vigilance/qa_rmp_qr_pgr-eng.php.
24. Henney, J.E., February, 2000. Plans for the fiscal year 2001 budget. Statement before the House Subcomittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies.
25. Henningfield J.E., Schuster C.R. Risk management and post-marketing surveillance of CNS drugs. Drug Alcohol Depend. 2009, 105(Suppl. 1):S56-S64.
26. Johanson C.-E., Balster R.L., Henningfield J.E., Schuster C.R., Anthony J.C., Barthwell A.G., Coleman J.J., Dart R.C., Gorodetzky C.W., O'Keeffe C., Sellers E.M., Vocci F., Walsh S.L. Risk management and post-marketing surveillance for the abuse of medications acting on the central nervous system: expert panel report. Drug Alcohol Depend. 2009, 105(Suppl. 1):S65-S71.
27. Johanson, C.-E., Schuster, C.R., Hatsukami, D., Vocci, F. (Eds.), 2003. Abuse liability assessment of CNS Drugs. Drug Alcohol Depend. 70 (Suppl. 3), S1-S114.
28. Leiderman D. Risk Management of drug products and the U.S. Food and Drug Administration: evolution and context. Drug Alcohol Depend. 2009, 105(Suppl. 1):S9-S13.
29. May E.L., Jacobson A.E. The committee on problems of drug dependence: a legacy of the National Academy of Science. A historical account. Drug Alcohol Depend. 1989, 23:183-218.
30. McCormick C.G. Regulatory challenges for new formulations of controlled substances in today's environment. Drug Alcohol Depend. 2006, 83(Suppl. 1):S63-S67.
31. McCormick C., Henningfield J., Haddox J.D., Varaghese S., Lindholm A., Rosen S., Wissel J., Carter L.C., Seeger V., Johnson R.E. Case histories in pharmaceutical risk management. Drug Alcohol Depend. 2009, 105(Suppl. 1):S42-S55.
32. Negus S.S., Fantegrossi W. Overview of conference on preclinical abuse liability testing: current methods and future challenges. CPDD News and Views. Drug Alcohol Depend. 2008, 92:301-306.
33. Sapienza F.L. Abuse deterrent formulations and the Controlled Substances Act. Drug Alcohol Depend. 2006, 83(Suppl. 1):S23-S30.
34. Schnoll S.H., Ertischek M.D., Henningfield J.E. Risk management programs: a supplement to the Controlled Substances Act. Food Drug Law Regul. Educ. 2006, 4:19-23.
35. Schuster C.R., Henningfield J.E. Conference on abuse liability assessment of CNS drugs. Drug Alcohol Depend. 2003, 70(Suppl. 3):S1-S4.
36. Sellers, E.M., Johanson, C.-E. (Eds.), 2006. Drug formulation and abuse liability. Drug Alcohol Depend. 83 (Suppl. 1), S1-S89.
37. Sellers E.M., Schuster C.R. Conference on drug formulations and abuse liability. Drug Alcohol Depend. 2006, 83(Suppl. 1):S1-S3.
38. Spillane J., McAllister W.B. Keeping the lid on: a century of drug regulation and control. Drug Alcohol Depend. 2003, 70(Suppl. 3):S5-S12.
39. The Expert Panel Abuse liability assessment of CNS drugs: conclusions, recommendations, and research priorities. Drug Alcohol Depend. 2003, 70(Suppl. 3):S107-114.
40. Woodcock, J., December, 2002. Concerns regarding Accutane (isotretinoin). Statement before the Subcommittee on Oversight and Investigations. Committee on Energy and Commerce. U.S. House of Representatives. Available at: (accessed on June 9, 2009). http://www.fda.gov/NewsEvents/Testimony/ucm115126.htm.