FDA In Brief > FDA In Brief: FDA affirms its commitment to efficient adoption of Risk Evaluation and Mitigation Strategy plans and to making sure they do not impede generic drug development

FDA In Brief > FDA In Brief: FDA affirms its commitment to efficient adoption of Risk Evaluation and Mitigation Strategy plans and to making sure they do not impede generic drug development

FDA In Brief: FDA affirms its commitment to efficient adoption of Risk Evaluation and Mitigation Strategy plans and to making sure they do not impede generic drug development 

Today, the U.S. Food and Drug Administration issued guidance for industry, REMS: FDA’s Application of Statutory Factors in Determining When a REMS Is Necessary. This guidance clarifies how FDA determines whether a REMS is necessary to ensure that the benefits of a drug outweigh its risks. It finalizes the draft guidance, issued on September 21, 2016.  ### The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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