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
You may also be interested in...
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
Further safety studies of Procter & Gamble's testosterone patch Intrinsa are necessary prior to approval because of the potential for broad off-label use of the female sexual dysfunction therapy, FDA's Reproductive Health Drugs Advisory Committee said Dec. 2
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011