Female Sexual Dysfunction Guidance Should Be Revised, Intrinsa Cmte. Says
Executive Summary
FDA should consider revising the recommended primary endpoint for female sexual dysfunction clinical trials, members of the Reproductive Health Drugs Advisory Committee said Dec. 2
You may also be interested in...
A New Dawn For Female Sex Dysfunction Drugs? FDA Meeting Cheers Sponsors
Experts convened by FDA to discuss female sexual dysfunction disorders, including problems with desire and arousal, settle on endpoints contrary to new DSM, but are in line with trials of Sprout’s flibanserin, the leading drug in development.
Full Safety Data For Female Sexual Disorder Drugs Could Come Post-Approval
Sponsors of testosterone therapies for hypoactive sexual desire disorder may be able to pursue NDA approval with some safety data submitted pre-approval and further safety data collected post-approval
Full Safety Data For Female Sexual Disorder Drugs Could Come Post-Approval
Sponsors of testosterone therapies for hypoactive sexual desire disorder may be able to pursue NDA approval with some safety data submitted pre-approval and further safety data collected post-approval