Cymbalta Pregnancy Risk Fit FDA's New Power To Mandate Post-Market Study
This article was originally published in Pharmaceutical Approvals Monthly
FDA's application of its new ability to require - as opposed to request - post-marketing studies under the FDA Amendments Act is on display in the review of a fibromyalgia claim for Lilly's Cymbalta (duloxetine)
You may also be interested in...
Theravance is the last of the three sponsors from a marathon advisory committee review of antibiotics for cSSSI to get an action letter; as the only one with a positive vote, it’s the only one that doesn’t need further trials.
FDA has used its new authority to impose a Risk Evaluation and Mitigation Strategy on roughly one-third of all new molecular entities approved since the REMS provisions of the FDA Amendments Act took effect at the end of March.