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International Drug Control Policy: Background and U.S. Responses

Description: This report discusses challenges created by the global illegal drug trade, including: undermining political and regional stability, bolstering the role and capabilities of transnational criminal organizations in the drug trade, and the burden caused by drug use an addition on local communities and economic development. In addition, this report discusses U.S. policy efforts to thwart illegal drug trade.
Date: October 16, 2012
Creator: Wyler, Liana Sun
Partner: UNT Libraries Government Documents Department

Legal Authorities Under the Controlled Substances Act to Combat the Opioid Crisis

Description: This report discusses legal authorities available to the federal government under the Controlled Substances Act (CSA) that could be used to combat the opioid epidemic. The report then examines DEA initiatives and actions taken, pursuant to its legal authorities under the CSA, which specifically target the abuse of opioids. It concludes by discussing selected opioid-related legislative proposals in the 115th Congress that would amend the CSA.
Date: April 16, 2018
Creator: Yeh, Brian T.
Partner: UNT Libraries Government Documents Department

FDA Risk Evaluation and Mitigation Strategies (REMS): Description and Effect on Generic Drug Development

Description: This report provides a brief history of FDA drug regulation, describes FDA's early risk management programs, and focuses on the agency's current risk management authorities, specifically risk evaluation and mitigation strategies (REMS). The report also discusses issues that have arisen as a result of REMS, particularly the impact on generic drug competition. While this report generally focuses on REMS in the context of generic drug development, the issues discussed are also relevant to biological and biosimilar product development.
Date: March 16, 2018
Creator: Dabrowska, Agata
Partner: UNT Libraries Government Documents Department