New legislation intended to help protect patients from undue risks associated with medical products provided the FDA with strengthened post-marketing drug safety oversight. The law allows the FDA to require that sponsors submit Risk Evaluation and Mitigation Strategies (REMS) to ensure that the benefits of the drug outweigh the risks. So far, implementation and interpretation of the law has not been without problems. Now some in CDRH are asserting REMS-like powers for devices. Find out how the FDA’s new post-marketing safety restrictions may mean higher costs for manufacturers and significant approval delays when you join FDC Reports and Sidley for this exclusive web conference.
REMS: The New FDA Post-Market Safety Restrictions for Drugs And Devices
November 13, 2008