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FDA Authorization Act of 2017 (FDARA, P.L. 115-52)

Description: This report presents an overview of the Food and Drug Administration Reauthorization Act (FDARA) of 2017 by title and section, providing a narrative context for each title, as well as a brief description of each section.
Date: September 21, 2017
Creator: Sarata, Amanda K.; Dabrowska, Agata; Johnson, Judith A. & Thaul, Susan
Item Type: Refine your search to only Report
Partner: UNT Libraries Government Documents Department
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FDA Final Rule Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco

Description: This report discusses FDA's initial failed attempt at regulating tobacco products under the then existing provisions of the FFDCA, summarizes FDA's current tobacco rule-reissued pursuant to statutory authority granted under the FSPTCA, and compares the reissued rule's provisions to the youth access, advertising, and marketing restrictions that went into effect pursuant to the 1998 Master Settlement Agreement between the states and the tobacco companies.
Date: June 24, 2010
Creator: Redhead, C. Stephen & Garvey, Todd
Item Type: Refine your search to only Report
Partner: UNT Libraries Government Documents Department
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FDA FY2009 Appropriations

Description: No Description Available.
Date: November 13, 2008
Creator: Thaul, Susan; Johnson, Judith A.; Lister, Sarah A.; Porter, Donna V.; Smith, Pamela W. & Williams, Erin D.
Item Type: Refine your search to only Report
Partner: UNT Libraries Government Documents Department
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The FDA FY2009 Budget

Description: This report discusses the Food and Drug Administration's (FDA's) FY2009 budget request of $2.676 billion that would provide a 17.9% increase ($406 million) over FY2008. It includes an overview and breakdowns for specific programs: Foods Program, Human Drugs Program, Biologics program, Animal Drugs and Feed Program, and the Devices and Radiological Health Program.
Date: August 25, 2008
Creator: Johnson, Judith A.; Lister, Sarah A. & Porter, Donna V.
Item Type: Refine your search to only Report
Partner: UNT Libraries Government Documents Department
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The FDA Medical Device User Fee Program

Description: This report describes current law regarding medical device user fees, the impact of MDUFA on FDA review time of various medical device program budget, the MUDFA III proposal (legislative language and performance goals agreement), and issues that Congress is likely to take up as it works on the reauthorization of the medical device user fee program.
Date: April 24, 2012
Creator: Johnson, Judith A.
Item Type: Refine your search to only Report
Partner: UNT Libraries Government Documents Department
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FDA Regulation of Follow-On Biologics

Description: This report provides information about the FDA Regulation of Follow-On Biologics. A follow-on biologic is similar to the innovator product name by the pharmaceutical or biotechnology industry.
Date: August 6, 2007
Creator: Johnson, Judith A.
Item Type: Refine your search to only Report
Partner: UNT Libraries Government Documents Department
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FDA Regulation of Follow-On Biologics

Description: This report provides information about the FDA Regulation of Follow-On Biologics. A follow-on biologic is similar to the innovator product name by the pharmaceutical or C industry.
Date: April 7, 2008
Creator: Johnson, Judith A.
Item Type: Refine your search to only Report
Partner: UNT Libraries Government Documents Department
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FDA Regulation of Tobacco Products: A Historical, Policy and Legal Analysis

Description: This report begins with an overview of the FDA's 1996 tobacco rule that includes a summary of the agency's arguments for asserting jurisdiction over tobacco products. The report then reviews the 1997 proposed national tobacco settlement, which would have codified the FDA rule and given the agency explicit authority to regulate tobacco products as medical devices.
Date: July 30, 2008
Creator: Redhead, C. Stephen & Burrows, Vanessa K.
Item Type: Refine your search to only Report
Partner: UNT Libraries Government Documents Department
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FDA’s Authority to Ensure That Drugs Prescribed to Children Are Safe and Effective

Description: The report describes why research on a drug's pharmacokinetics, safety, and effectiveness in children might be necessary. This report then presents why the marketplace has not provided sufficient incentives to manufacturers of drugs approved for adult use to study their effects in children. It also analyzes the impact of BPCA and PREA have had on pediatric drug research.
Date: June 25, 2012
Creator: Thaul, Susan
Item Type: Refine your search to only Report
Partner: UNT Libraries Government Documents Department
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The FDA’s Authority to Recall Products

Description: This report provides information about the The FDA’s Authority to Recall Products. The FDA had fielded increasing number of question regarding recalls of unsafe imports, including jalapeno peppers.
Date: September 16, 2008
Creator: Burrows, Vanessa K.
Item Type: Refine your search to only Report
Partner: UNT Libraries Government Documents Department
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The FDA’s Authority to Recall Products

Description: This report provides information about the The FDA’s Authority to Recall Products. The FDA had fielded increasing number of question regarding recalls of unsafe imports, including jalapeno peppers.
Date: September 11, 2007
Creator: Burrows, Vanessa K.
Item Type: Refine your search to only Report
Partner: UNT Libraries Government Documents Department
open access

The FDA’s Authority to Recall Products

Description: This report provides information about the The FDA’s Authority to Recall Products. The FDA had fielded increasing number of question regarding recalls of unsafe imports, including jalapeno peppers.
Date: August 4, 2010
Creator: Burrows, Vanessa K.
Item Type: Refine your search to only Report
Partner: UNT Libraries Government Documents Department
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