PTSM: Pharmaceutical Technology Sourcing and Management-01-07-2015

CMOs are becoming sought-after partners as a result of their use of innovative technologies, single-use bioreactors, and other novel bioprocessing services.

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).

FDA delays enforcement of product tracing requirements to May 1, 2015, providing trading partners more time to comply.

Analytical and procedural deficiencies result in FDA warning letter for Novacyl Wuxi Pharmaceutical.

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.

New organization offers support to contract research organizations and contract manufacturing organizations in the New England area.