HELP, E&C release discussion draft of User Fees Reauthorization
April 17
July 21
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.
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.
