Case histories in pharmaceutical risk management

Agonist Medications for the Treatment of Cocaine Use Disorder

“…For example, buprenorphine products for treatment of opioid dependence are scheduled under the CSA and are subject to REMS (SAMHSA, 2014a). Approval of a methylphenidate transdermal system in 2006 was in the context of risk-management requirements to address concerns, including concerns about abuse liability, posed by the transdermal delivery approach (McCormick et al, 2009).…”

Pharmaceutical industry perspective on risk evaluation and mitigation strategies: manufacturer take heed

“…Of concern in developing REMS class-wide opioid programs is to balance the needs of patients and health professionals without mandating unduly burdensome restrictions [35]. On May 16, 2011, the FDA met with members of the Industry Working Group and other sponsors of long-acting and extendedrelease opioids to discuss next steps in implementing REMS for these products through a single shared system [36].…”

Risk management and post-marketing surveillance for the abuse of medications acting on the central nervous system: Expert Panel Report

“…Subsequently, the October 2008 CPDD conference was organized around these four background papers as well as four case study presentations that highlighted risk management plans developed by pharmaceutical companies for recently approved medications. The background papers and a paper summarizing the case study presentations were peer-reviewed and edited for this supplemental issue (Leiderman, 2009; Carter and Griffiths, 2009; Dart, 2009; Dasgupta and Schnoll, 2009; McCormick et al 2009). At the meeting, the authors of all these papers were asked to give a summary presentation.…”