A milestone week for PBOA at the GDUFA hearings, BIO and beyond
It’s been a while since the last blog update! I apologize, but I’ve been engaged in so much work on behalf of the PBOA — visiting Capitol Hill (repeatedly), hosting our first Regulatory/Legislative Workshop, exhibiting at (and putting panels together for) INTERPHEX, preparing for the upcoming GDUFA public hearing, conducting our Q1 board meeting, visiting our member companies.
In which we cover the PDA Annual Meeting and DCAT Week, even though they overlap and are 3 time zones apart.
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.