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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.
Partner: UNT Libraries Government Documents Department
open access

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.
Partner: UNT Libraries Government Documents Department
open access

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.
Partner: UNT Libraries Government Documents Department
open access

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.
Partner: UNT Libraries Government Documents Department
open access

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
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: September 16, 2008
Creator: Burrows, Vanessa K.
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: September 11, 2007
Creator: Burrows, Vanessa K.
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.
Partner: UNT Libraries Government Documents Department
open access

Federal Farm Promotion ("Check-off") Programs

Description: The U.S. Supreme Court in 2005 affirmed the constitutionality of the so-called beef check-off program, one of the 18 generic promotion programs for agricultural products that are now active nationally. Supporters view check-offs as economically beneficial self-help activities that need minimal government involvement or taxpayer funding. Producers, handlers, and/or importers are required to pay an assessment, usually deducted from revenue at time of sale - thus the name check-off. However, some … more
Date: October 20, 2008
Creator: Becker, Geoffrey S.
Partner: UNT Libraries Government Documents Department
open access

Federal Food Assistance: Hurricane Katrina

Description: This report discusses the federal food assistance programs for those affected by Hurricane Katrina, making them automatically eligible for maximum benefits. It also is providing substantial amounts of direct food aid drawn from its commodity stocks.
Date: September 13, 2005
Creator: Richardson, Joe
Partner: UNT Libraries Government Documents Department
open access

Federal Food Assistance in Disasters: Hurricanes Katrina and Rita

Description: This report discusses federal food assistance in response to Hurricanes Katrina and Rita. The Food Stamp program, child nutrition programs, the Special Supplemental Nutrition Program for Women, Infants and Children (the WIC program), and federally donated food commodities delivered through relief organizations provide major support in disasters like Hurricanes Katrina and Rita. Existing laws authorize the Agriculture Department to change eligibility and benefit rules to facilitate emergency aid… more
Date: September 23, 2005
Creator: Richardson, Joe
Partner: UNT Libraries Government Documents Department
open access

Federal Food Assistance Programs

Description: This report details the forms of food assistance such as the provision of meals, food subsidies, aid in food purchase, provision of foodstuffs, and supportive food services which are administered by three departments; Department of Agriculture, Community Services Administration, and the Department of Health, Education, and Welfare.
Date: September 2, 1976
Creator: Michelman, Kathy
Partner: UNT Libraries Government Documents Department
open access

The Federal Food Safety System: A Primer

Description: Report concerning food safety, the resources required to ensure food safety, and whether federal food safety laws themselves, first enacted in the early 1900s, have kept pace with the significant changes that have occurred in the food production, processing, and marketing sectors since then.
Date: January 11, 2011
Creator: Johnson, Renée
Partner: UNT Libraries Government Documents Department
open access

The Federal Food Safety System: A Primer

Description: The combined efforts of the food industry and the regulatory agencies often are credited with making the U.S. food supply among the safest in the world. Nonetheless, many food-related health issues persist. At issue is whether the current U.S. regulatory system has the resources and structural organization to protect consumers from these dangers. Also at issue is whether the federal food safety laws themselves, first enacted in the early 1900s, have kept pace with the significant changes that h… more
Date: September 22, 2010
Creator: Johnson, Renée
Partner: UNT Libraries Government Documents Department
open access

The Federal Food Safety System: A Primer

Description: The combined efforts of the food industry and the regulatory agencies often are credited with making the U.S. food supply among the safest in the world. Nonetheless, many food-related health issues persist. At issue is whether the current U.S. regulatory system has the resources and structural organization to protect consumers from these dangers. Also at issue is whether the federal food safety laws themselves, first enacted in the early 1900s, have kept pace with the significant changes that h… more
Date: December 15, 2010
Creator: Johnson, Renée
Partner: UNT Libraries Government Documents Department
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