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

4 April 2019 - Today, the U.S. FDA issued guidance for industry, REMS: FDA’s Application of Statutory Factors in Determining When ...

Read more →

FDA statement from Commissioner announcing efforts to improve the quality of the information used to assess the effectiveness of REMS programs in supporting the safe use of medications

24 January 2019 - In making decisions about whether the benefits of a drug outweighs its risks, there are many ...

Read more →