21 July 2020 - The US FDA Amendments Act of 2007 gave the FDA authority to require a Risk Evaluation and ...
4 April 2019 - Today, the U.S. FDA issued guidance for industry, REMS: FDA’s Application of Statutory Factors in Determining When ...
24 January 2019 - In making decisions about whether the benefits of a drug outweighs its risks, there are many ...