PTSM: Pharmaceutical Technology Sourcing and Management
January 05, 2015
Outsourcing
11
1
CMOs are becoming sought-after partners as a result of their use of innovative technologies, single-use bioreactors, and other novel bioprocessing services.
January 05, 2015
Regulatory
11
1
FDA’s Center for Drug Evaluation and Research implements its reorganization to bolster programs and policies to ensure drug with its “super” Office of Pharmaceutical Quality (OPQ).
December 31, 2014
Regulatory
11
1
FDA delays enforcement of product tracing requirements to May 1, 2015, providing trading partners more time to comply.
December 31, 2014
API Synthesis and Manufacturing
11
1
Analytical and procedural deficiencies result in FDA warning letter for Novacyl Wuxi Pharmaceutical.
December 22, 2014
Regulatory
11
1
FDA set several milestones in approving more new, important drugs and biologics in 2014. Breakthrough drug designations went through through the roof, speeding more new therapies for cancer and critical conditions to patients.
December 17, 2014
Outsourcing
11
1
New organization offers support to contract research organizations and contract manufacturing organizations in the New England area.