Pharma & Biopharma Outsourcing Association Corporate Profile

Pharma & Biopharma Outsourcing Association
Pharma & Biopharma Outsourcing Association
10 Alta Vista Dr.
Ringwood, NJ 07456
United States
Phone: 201-788-7994

Content

  • CMOs and GDUFA: Shaping a New World

    In July 2012, the U.S. Congress enacted the Food and Drug Administration Safety and Innovation Act (FDASIA), which contained the Generic Drug User Fee Amendments (GDUFA). GDUFA has noble goals in its first five year term (FY 2013 - FY 2017): improving safety, access and supply chain transparency for...
  • CMO/CDMOs: Looking Ahead

    The number one trend from last year’s edition demands a repeat (see - (http://pharma-bio.org/pdfs/CPhI%20annual%20report%202015.pdf - page 46). The CMO/CDMO sector remains fragmented, and business logic dictates that the sector needs to consolidate (or rationalize, if that’s your term of choice). It...
  • CMO/CDMOs: Challenges and Opportunities

    “All predictions null-and-void if Trump wins the US Presidential election:" That’s how I closed out last year’s ‘Looking Ahead’ piece. Suffice to say, my crystal ball is C-R-A-C-K-E-D, and my backup Magic 8-Ball’s answer to everything is, “Reply hazy. Try again later."

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