September 28

2015 PDA/FDA Joint Regulatory Conference

The 2015PDA/FDA Joint Regulatory Conference offers the unique opportunity to talk with FDA representatives and industry experts to discover firsthand how to comply with regulatory global strategies and industry strategic initiatives from leaders and advocates who are shaping the global regulatory compliance landscape and take home best practices for compliance.

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.

September 26

How Will GDUFA Impact Contract Manufacturers and Packagers?

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.