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Drug Compounding: FDA Authority and Possible Issues for Congress

Description: This report discusses legislation regulating the compounding of drugs by pharmacies to remove certain ingredients from a standard approved drug for patients with allergies, or for a medical clinic to keep on hand. It outlines various arguments for and against further regulation of the practice by the FDA and potential Congressional actions.
Date: January 5, 2018
Creator: Dabrowska, Agata
Item Type: Refine your search to only Report
Partner: UNT Libraries Government Documents Department
open access

The SUPPORT for Patients and Communities Act (P.L. 115-271): Food and Drug Administration and Controlled Substance Provisions

Description: This report summarizes the provisions in Title III--the FDA (Food and Drug Administration) and Controlled Substance Provisions, as well as Section 4004 "Modernizing the Reporting Requirements of Biological and Biosimilar Products" in Title IV--Offsets.
Date: November 15, 2018
Creator: Dabrowska, Agata; Green, Victoria R.; Sacco, Lisa N. & Yeh, Brian T.
Item Type: Refine your search to only Report
Partner: UNT Libraries Government Documents Department
open access

Public Health Service Agencies: Overview and Funding (FY2015-FY2017)

Description: This report gives a brief overview of the eight agencies within the Department of Health and Human Services (HHS) which are designated components of the U.S. Public Health Services (PHS), and summarizes its funding for FY2015 through FY2017.
Date: May 19, 2016
Creator: Redhead, C. S.; Dabrowska, Agata; Bagalman, Erin; Heisler, Elayne J.; Johnson, Judith A.; Lister, Sarah A. et al.
Item Type: Refine your search to only Report
Partner: UNT Libraries Government Documents Department
open access

Comparison of the Bills to Extend State Children's Health Insurance Program (CHIP)

Description: This report discusses the State Children's Health Insurance Program (CHIP) and compares and summarizes the provisions in the KIDS Act and in Division B of the CHAMPIONING HEALTHY KIDS Act.
Date: January 17, 2018
Creator: Mitchell, Alison; Baumrucker, Evelyne P.; Dabrowska, Agata; Davis, Patricia A.; Gopalan, Susannah V. & Sarata, Amanda K.
Item Type: Refine your search to only Report
Partner: UNT Libraries Government Documents Department
open access

Nutrition Labeling of Restaurant Menu and Vending Machine Items

Description: This report discusses nutrition labeling for items on restaurant menus, in vending machines, prepared food at groceries, and entertainment venues which is required by the Patient Protection and Affordable Care Act passed in 2010 but now due to be fully implemented in May 2018.
Date: February 5, 2018
Creator: Dabrowska, Agata
Item Type: Refine your search to only Report
Partner: UNT Libraries Government Documents Department
open access

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 biologic… more
Date: March 16, 2018
Creator: Dabrowska, Agata
Item Type: Refine your search to only Report
Partner: UNT Libraries Government Documents Department
open access

Comparison of the Bills to Extend State Children's Health Insurance Program (CHIP) Funding

Description: This report discusses bills and their provisions related to extending funding for the State Children's Health Insurance Program (CHIP) whose funding expired at the end of the 2017 fiscal year. The House passed the CHAMPIONING HEALTHY KIDS Act on November 3, 2017, by a vote of 242 to 174. This report contains a table that provides an overview of the provisions in the KIDS Act and Division B of the CHAMPIONING HEALTHY KIDS Act as baselined against current law. The section following the table prov… more
Date: November 3, 2017
Creator: Mitchell, Allison; Baumrucker, Evelyne P.; Dabrowska, Agata; Davis, Patricia A.; Gopalan, Susannah V. & Sarata, Amanda K.
Item Type: Refine your search to only Report
Partner: UNT Libraries Government Documents Department
open access

Comparison of the Bills to Extend State Children's Health Insurance Program (CHIP) Funding

Description: This report discuses recently proposed bills in the Senate (KIDS Act) and the House (HEALTHY KIDS Act) to extend funding for the State Children's Health Insurance Program (CHIP) which is currently unfunded for the 2018 fiscal year and running off of unused funds in each state from previous years. On October 4, 2017, both the Senate Finance Committee and the House Energy and Commerce Committee had markups on different bills that would extend CHIP federal funding through FY2022, among other provi… more
Date: October 23, 2017
Creator: Mitchell, Alison; Baumrucker, Evelyne P.; Dabrowska, Agata; Davis, Patricia A.; Gopalan, Susannah V. & Sarata, Amanda K.
Item Type: Refine your search to only Report
Partner: UNT Libraries Government Documents Department
open access

Public Health Service Agencies: Overview and Funding (Fiscal Year 2016-Fiscal Year 2018)

Description: This report outlines the funding types received by U.S. Public Health Service agencies and provides brief overviews of each agency and their recent funding trends. The eight agencies discussed are the Agency for Healthcare Research and Quality (AHRQ), the Centers for Disease Control and Prevention (CDC), the Agency for Toxic Substances and and Disease Registry (ATSDR), the Food and Drug Administration (FDA), the Health Resources and Services Administration (HRSA), the Indian Health Service (IHS… more
Date: August 16, 2017
Creator: Redhead, C. Stephen; Dabrowska, Agata; Bagalman, Erin; Heisler, Elayne J.; Johnson, Judith A.; Lister, Sarah A. et al.
Item Type: Refine your search to only Report
Partner: UNT Libraries Government Documents Department
open access

FDA Human Medical Product User Fee Programs: In Brief

Description: This report discusses FDA human medical product user fees for prescription drugs, medical devices, generic drugs, and biosimilars which are charged to companies producing the products and make up a large portion of the FDA's revenues. User fees are authorized in legislation on a five-year cycle, with authority for their actual collection and expenditure provided each year through the annual appropriations process. Appendix A outlines various features of the user fee programs.
Date: November 21, 2017
Creator: Dabrowska, Agata; Johnson, Judith A.; Sarata, Amanda K. & Thaul, Susan
Item Type: Refine your search to only Report
Partner: UNT Libraries Government Documents Department
open access

Prescription Drug User Fee Act (PDUFA): 2017 Reauthorization as PDUFA VI

Description: This report discusses the Prescription Drug User Fee Act (PDUFA) and its reauthorization as PDUFA VI. The bill allows the FDA to collect fees from pharmaceutical companies to support the review process for human drug applications. The various stages of drafting and passing the bill as well as changes from the most recent PDUFA are included.
Date: June 8, 2017
Creator: Dabrowska, Agata & Thaul, Susan
Item Type: Refine your search to only Report
Partner: UNT Libraries Government Documents Department
open access

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. It does not discuss antitrust issues raised by restricted distribution systems.
Date: April 11, 2017
Creator: Dabrowska, Agata
Item Type: Refine your search to only Report
Partner: UNT Libraries Government Documents Department
open access

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
open access

Dietary Guidelines for Americans: Frequently Asked Questions

Description: This report provides responses to frequently asked questions about the Dietary Guidelines for Americans (DGA), including the DGA development process, as well as specific recommendations contained in the 2015-2020 DGA. The DGA provides federally-developed food-based recommendations for Americans two years of age and older, designed to promote health and prevent disease.
Date: February 2, 2016
Creator: Dabrowska, Agata
Item Type: Refine your search to only Report
Partner: UNT Libraries Government Documents Department
open access

Public Health Service Agencies: Overview and Funding (FY2010-FY2016)

Description: This report gives a brief overview of the eight agencies within the Department of Health and Human Services (HHS) which are designated components of the U.S. Public Health Services (PHS), and summarizes its funding for FY2010 through FY2016.
Date: October 13, 2015
Creator: Redhead, C. S. & Dabrowska, Agata
Item Type: Refine your search to only Report
Partner: UNT Libraries Government Documents Department
open access

Childhood Overweight and Obesity: Data Brief

Description: This report provides an overview of the data being used to inform federal obesity policy. It presents an overview of obesity statistics among children and adolescents, and includes a discussion of obesity measurement, trends in obesity rates, and differences that exist across gender, race, ethnicity, socioeconomic status, and geographic location.
Date: November 13, 2014
Creator: Dabrowska, Agata
Item Type: Refine your search to only Report
Partner: UNT Libraries Government Documents Department
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