Outsourcing
Modest Expectations for CMOs and Biosimilars
Jim Miller
Biosimilars may add a nice increment to the pipeline opportunities, for CMOs, but they are unlikely to be a bonanza for the industry.
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PBOA Supports Legislation to Protect FDA User Fees
The Pharma & Biopharma Outsourcing Association announced its support of legislation that would preserve FDA user fees from sequestration.
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API Synthesis & Manufacturing
The Challenge of Resolving Agents for Chiral Resolution
Cynthia A. Challener
Finding efficient methods for the production of chirally pure APIs remains an important topic in the pharmaceutical industry.
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Supply Chain
Mitigating Cold-Chain Risks
Wanis Kabbaj and Dirk Van Peteghem
Market growth, costs, and regulations, and drive pharmaceutical companies to find new ways to mitigate risk in the cold chain.
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Regulatory Developments
Significant Changes in the 2014 IPEC Significant Change Guide
Kevin J. McGlue
A revision and modernization of the IPEC Significant Change Guide incorporates concepts of risk assessment.
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FDA Tightens Drug Security Regulations
Jill Wechsler
New rules for tracing drugs through the supply chain and policies for drug compounders change the regulatory landscape.
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