FDA Examining Citizen Petition Review Process To Speed Generic Approvals
This article was originally published in The Pink Sheet Daily
Executive Summary
The agency is looking at its review process for citizen petitions to expedite decisionmaking, but FDA has not settled on a course of action, Acting Commissioner Crawford and CDER Acting Director Galson tell GPhA. Citizen petitions have “got me losing sleep at night,” OGD Director Buehler says.