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Systematic and Efficient Analytical Method Development for A Speedy Clinical Product Development
October 15, 2014
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Outsourcing
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.
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New England CRO/CMO Council Debuts
New organization offers support to contract research organizations and contract manufacturing organizations in the New England area.
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Developing a Comprehensive Tool Kit for Microbial Identification
November 18, 2014
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Regulatory Developments
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 the roof, speeding more new therapies for cancer and critical conditions to patients.
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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).
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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.
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Enhancing Quality and Process Efficiency using Continuous Manufacturing Technology for Drug Substance and Drug Product
January 13, 2015 at 11:00 AM EST
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API Synthesis & Manufacturing
Chinese API and Drug Manufacturer Issued Warning Letter
Analytical and procedural deficiencies result in FDA warning letter for Novacyl Wuxi Pharmaceutical.
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Supply Chain
Dual Sourcing and the Single-Use Supply Chain
A break in the supply of single-use materials and systems can disrupt a biomanufacturing process. Dual sourcing can reduce risk, but also open new challenges.
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