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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
Partner: UNT Libraries Government Documents Department
open access

Frequently Asked Questions About Prescription Drug Pricing and Policy

Description: This report will address frequently asked questions about government and private-sector policies that affect drug prices and availability. Among the prescription drug topics covered are federally funded research and development, regulation of direct-to-consumer advertising, legal restrictions on reimportation, and federal price negotiation. The report provides a broad overview of the issues as well as references to more in-depth CRS products. The appendixes provide references to relevant congre… more
Date: May 2, 2017
Creator: Kirchhoff, Suzanne M.; Johnson, Judith A. & Thaul, Susan
Partner: UNT Libraries Government Documents Department
open access

CRISPR Gene Editing Research in Embryos Generates Scientific and Ethics Debate

Description: This report discusses the results of a recent experiment on the use of gene modification for decreasing the chance of children having hypertrophic cardiomyopathy which was done through the use of CRISPR to modify the genes of human embryos at a private facility. Restrictions on the use of public funds for such studies, a brief explanation of the science, and ethical concerns are discussed.
Date: September 12, 2017
Creator: Sargent, John F., Jr.; Sarata, Amanda K. & Johnson, Judith A.
Partner: UNT Libraries Government Documents Department
open access

Biologics and Biosimilars: Background and Key Issues

Description: This report discusses biologic and biosimilar medicines and their production and approval by the FDA. Recent legislation regarding FDA approval regulations and federal research and drug development are also discussed.
Date: October 27, 2017
Creator: Johnson, Judith A.
Partner: UNT Libraries Government Documents Department
open access

Telehealth Services Proposed for Medicare Part B Reimbursements, 2018: Fact Sheet

Description: This report discusses telehealth services covered under Medicare and describes the five conditions that a telehealth service must meet to be covered and paid for under Medicare Part B, provides an overview of how the Secretary of the Department of Health and Human Services (HHS) adds telehealth services to Medicare's reimbursable list, and includes a table listing the proposed telehealth services to be added to the CY2018 list for Medicare reimbursement.
Date: November 15, 2017
Creator: Elliott, Victoria L.
Partner: UNT Libraries Government Documents Department
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