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in creator/contributor: "Dabrowska, Agata"  
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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. 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

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
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