The Food and Drug Administration (FDA) and the generic drug manufacturing industry—including representatives of generic pharmaceutical manufacturers, active pharmaceutical ingredient manufacturers and contract manufacturing organizations— have reached agreement on a package of program enhancements and resource commitments to reauthorize the Generic Drug User Fee Amendments of 2012 (GDUFA), which are set to expire next year.   The Pharma & Biopharma Outsourcing Association (PBOA) lauded the...