FDA Risk Evaluation and Mitigation Strategies (REMS): Description and Effect on Generic Drug Development (open access)

FDA Risk Evaluation and Mitigation Strategies (REMS): Description and Effect on Generic Drug Development

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
Object Type: Report
System: The UNT Digital Library
Newsletter of Texas State Representative Ernest Bailes: Volume 1, Issue 6, April 2017 (open access)

Newsletter of Texas State Representative Ernest Bailes: Volume 1, Issue 6, April 2017

Newsletter of Ernest Bailes for his constituents in district 18 discussing news, activities, and various updates related to work in the Texas legislature. It focuses on explaining the process of bills becoming Texas laws, and it updates information on the House passing the budget, the decision to deny the use of vouchers in Texas, firefighters' pensions, and the discussion of annexation.
Date: April 11, 2017
Creator: Bailes, Ernest James, IV
Object Type: Journal/Magazine/Newsletter
System: The Portal to Texas History