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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

Emergency Contraception: Plan B

Description: This report discusses the FDA approval of Plan B as a prescription drug, as well as the more recent and controversial FDA approval of Plan B as an OTC drug. Legal issues regarding the recent FDA decision are also discussed as well as various state policies that affect access to emergency contraceptives. In addition, the report discusses the Department of Justice guidelines for the treatment of sexual assault victims, which have been criticized by numerous organizations because they do not menti… more
Date: August 1, 2007
Creator: Johnson, Judith A. & Burrows, Vanessa K.
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.
Partner: UNT Libraries Government Documents Department
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The FDA 2009 Budget Request

Description: The Administration's FY2009 budget request of $2.4 billion for the Food and Drug Administration (FDA) would provide a 5.7% increase ($130 million) over FY2008. User fees would make up about 26% of the total amount requested and would account for 61% of the proposed increase. Budget documents indicate that the additional funding would provide for expanded activities to ensure the safety of foods and drugs, as well as to accelerate the availability of new medical products. About half of the reque… more
Date: May 19, 2008
Creator: Johnson, Judith A.; Lister, Sarah A.; Porter, Donna V.; Smith, Pamela W.; Thaul, Susan & Williams, Erin D.
Partner: UNT Libraries Government Documents Department
open access

Emergency Contraception: Plan B

Description: On August 24, 2006, the Food and Drug Administration announced the approval of an application to switch to Plan B, an emergency contraceptive, from a prescription-only drug to an over-the-counter drug for women 18 years of age and older. This report contains information on the background of the emergency contraceptive, FDA approval, legal issues, state policies, and related information.
Date: November 9, 2006
Creator: Johnson, Judith A.; Williams, Erin D. & Burrows, Vanessa K.
Partner: UNT Libraries Government Documents Department
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The “Farm Bill” in Brief

Description: This report discusses the farm bill, which renewed about every five years, governs federal farm and food policy. The Farm Security and Rural Investment Act of 2002 (P.L. 107-171) is the most recent omnibus farm bill, covering a wide range of programs including commodity price and income support, farm credit, agricultural conservation, research, rural development, and foreign and domestic food programs, among others.
Date: May 29, 2007
Creator: Johnson, Renée
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
open access

The Federal Food Safety System: A Primer

Description: This report discusses concerns about 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 17, 2014
Creator: Johnson, Renée
Partner: UNT Libraries Government Documents Department
open access

The Federal Food Safety System: A Primer

Description: This report is categorized into five categories: (I) Background, (II) The Agencies and Their Roles, (III) Congressional Committees, (IV) Funding for Federal Food Safety Programs and (V) Federal Food Safety Inspection.
Date: January 22, 2015
Creator: Johnson, Renée
Partner: UNT Libraries Government Documents Department
open access

The Federal Food Safety System: A Primer

Description: This report discusses concerns about 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: December 16, 2016
Creator: Johnson, Renée
Partner: UNT Libraries Government Documents Department
open access

The Federal Food Safety System: A Primer

Description: Numerous federal, state, and local agencies share responsibilities for regulating the safety of the U.S. food supply, which many experts say is among the safest in the world. This report discusses various food safety proposals in Congress, as well as agencies with food safety related responsibilities.
Date: August 18, 2010
Creator: Johnson, Renée
Partner: UNT Libraries Government Documents Department
open access

Food Fraud and "Economically Motivated Adulteration" of Food and Food Ingredients

Description: This report discusses food fraud, or the act of defrauding buyers of food and food ingredients for economic gain. It includes background information, an overview of available data and information repositories related to food fraud, federal activities involving food fraud, and Congressional actions involving food fraud.
Date: January 10, 2014
Creator: Johnson, Renée
Partner: UNT Libraries Government Documents Department
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Food Safety in the 111th Congress

Description: This report discusses whether the current food safety system has the resources, authority, and structural organization to safeguard the health of American consumers, who spend more than $1 trillion on food each year. Also at issue is whether federal food safety laws, 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: September 23, 2010
Creator: Johnson, Renée
Partner: UNT Libraries Government Documents Department
open access

Food Safety in the 111th Congress: H.R. 2749 and S. 510

Description: This report discusses whether the current food safety system has the resources, authority, and structural organization to safeguard the health of American consumers, who spend more than $1 trillion on food each year. Also at issue is whether federal food safety laws, 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: October 15, 2010
Creator: Johnson, Renée
Partner: UNT Libraries Government Documents Department
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