Dual Sourcing and the Single-Use Supply Chain
Five Trends Shaping Biopharma Manufacturing Outsourcing
CMOs are becoming sought-after partners as a result of their use of innovative technologies, single-use bioreactors, and other novel bioprocessing services.
OPQ Sets Stage for FDA’s Realigned Drug Oversight Structure
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
FDA delays enforcement of product tracing requirements to May 1, 2015, providing trading partners more time to comply.
Chinese API and Drug Manufacturer Issued Warning Letter
Analytical and procedural deficiencies result in FDA warning letter for Novacyl Wuxi Pharmaceutical.
More New Drugs and Faster Approvals
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 England CRO/CMO Council Debuts
New organization offers support to contract research organizations and contract manufacturing organizations in the New England area.
