U.S. Food & Drug Administration (FDA) Generic Drug User Fee Act (GDUFA) Update

FDA published a Federal Register notice to extend the closing date for public stakeholders to notify the Agency that they wish to participate in continued periodic stakeholder consultation meetings regarding the reauthorization of the Generic Drug User Fee Amendments of 2012 (GDUFA). Stakeholder participation is vital to GDUFA’s success, and the Agency is committed to providing ample time for interested parties to notify the FDA of their intent to do so. Stakeholders may notify FDA by email toGenericDrugPolicy@fda.hhs.gov by April 30, 2016.