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FDA’s Authority to Ensure That Drugs Prescribed to Children Are Safe and Effective

Description: The Food and Drug Administration (FDA) has approved for adult use many drugs never tested in children. Yet clinicians often prescribe them for children believing that the safety and effectiveness demonstrated with adults probably reasonably transfers to younger patients. The data show that this is not always true. To encourage industry to develop drugs and medical devices for pediatric use, Congress has established three programs. The Food and Drug Administration Amendments Act of 2007 (FDAAA, P.L. 110-85) reauthorized and strengthened two laws addressing drugs—the Best Pharmaceuticals for Children Act (BPCA) of 2002 and the Pediatric Research Equity Act (PREA) of 2003—and enacted a new law addressing devices—the Pediatric Medical Device Safety and Improvement Act (PMDSIA) of 2007. The historical approach of this report allows an understanding of how and why Congress took these steps.
Date: December 2, 2008
Creator: Thaul, Susan
Partner: UNT Libraries Government Documents Department

The World Drug Problem: UNGA Convenes for a Special Session

Description: This report briefly discusses the United Nations General Assembly (UNGA), which has convened in New York for a special session on "The World Drug Problem." It is the third time the UNGA will convene such a session on global drug issues. Previous special sessions on drugs were held in 1990 and 1998.
Date: April 20, 2016
Creator: Rosen, Liana W.
Partner: UNT Libraries Government Documents Department

The Comprehensive Addiction and Recovery Act of 2016 (S. 524): Comparison of Senate- and House-Passed Versions

Description: This report discusses selected differences and similarities between the Senate- and House-passed versions of the Comprehensive Addiction and Recovery Act of 2016 (CARA; S. 524), which aims to address the problem of opioid addiction in the United States. The two versions of the bill differ substantially. The scope of the differences may be illustrated by their structures: The Senate bill has 28 sections organized in 8 titles, whereas the House bill has 69 sections organized in 18 titles.
Date: May 23, 2016
Creator: Bagalman, Erin & Sacco, Lisa N.
Partner: UNT Libraries Government Documents Department

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

State Legalization of Recreational Marijuana: Selected Legal Issues

Description: This report summarizes the Washington and Colorado marijuana legalization laws and evaluates whether, or the extent to which, they may be preempted by the Controlled Substances Act (CSA) or by international agreements. It also describes and analyzes the U.S. Department of Justice's (DOJ's) response to these legalization initiatives. The report then identifies certain noncriminal consequences that marijuana users may face under federal law. Finally, the report closes with a description of selected legislative proposals introduced in the 113th Congress relating to the treatment of marijuana under federal law.
Date: January 13, 2014
Creator: Garvey, Todd & Yeh, Brian T.
Partner: UNT Libraries Government Documents Department

State Legalization of Recreational Marijuana: Selected Legal Issues

Description: This report summarizes the Washington and Colorado marijuana legalization laws and evaluates whether, or the extent to which, they may be preempted by the Controlled Substances Act (CSA) or by international agreements. It also highlights potential responses to these recent legalization initiatives by the U.S. Department of Justice (DOJ) and identifies other noncriminal consequences that marijuana users may face under federal law.
Date: April 5, 2013
Creator: Garvey, Todd & Yeh, Brian T.
Partner: UNT Libraries Government Documents Department

Governmental Drug Testing Programs: Legal and Constitutional Developments

Description: This report examines the current state of constitutional law on the subject of governmentally mandated drug testing in employment and of students in the public schools, which is followed by a brief review of federal drug-free workplace programs presently in effect.
Date: August 19, 2008
Creator: Carpenter, David H.
Partner: UNT Libraries Government Documents Department

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

Description: The report provides background information on drug cultivation, drug trafficking and the consequences of drug trade. 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: August 13, 2013
Creator: Wyler, Liana Sun
Partner: UNT Libraries Government Documents Department