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.
It’s a busy season for the PBOA and its members
Fall conference season is done, and it’s time to focus on the 2015 agenda
We weren’t planning on making a public launch of the Pharma & Biopharma Outsourcing Association on September 17, but it’s funny how things work out! I attended the FDA’s GDUFA Public Hearing on Policy Development in Hyattsville, MD that day with two members of our board of trustees, treasurer Tom Thorpe (Afton Scientific) and secretary Sam.