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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.
The Federal Food Safety System: A Primer
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.
Health Insurance: A Primer
This report provides information about Health Insurance where people buy insurance to protect themselves against the possibility of financial loss in the future. Americans obtain insurance in different settings and a variety of methods.
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