February 27

This Is Your Big Debut: the transcript

On September 17, 2014, the Pharma & Biopharma Outsourcing Association made its official debut in front of FDA at a public hearing to discuss the Generic Drug User Fee Amendments (GDUFA). During an open comments session of the hearing, PBOA President Gil Roth spoke to the panel about our members’ interests in seeing GDUFA’s Facility.