We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
Home » FDA Clarifies Steps to Submit Alternative Postmarket Reports
FDA Clarifies Steps to Submit Alternative Postmarket Reports
Generics sponsors hoping to submit the ICH’s alternative postmarket report, known as the the periodic benefit-risk evaluation report (PBRER), at a different frequency than required should plan to file a waiver request, the FDA said.