Current Class Of Risk Evaluation & Mitigation Strategies
This article was originally published in Pharmaceutical Approvals Monthly
Here is a general outline of the REMS FDA has mandated so far, as well as a listing of drugs where it has been announced that REMS are being developed or drugs with safety issues that could invoke a REMS.
You may also be interested in...
In separate warning letters, the US FDA says Biomedix (a maker of I.V. administration sets) and Unetixs Vascular (a maker of vascular diagnostic ultrasound systems) must hire outside consultants to review their quality systems after serious deficiencies were noted by agency investigators. A total of three enforcement missives were released by the FDA this week.
The German major's two leading products continue to perform well but there are not many potential blockbusters in the pipeline.