PTSM: Pharmaceutical Technology Sourcing and Management, Dec 5, 2007 - Pharmaceutical Technology

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PTSM: Pharmaceutical Technology Sourcing and Management, Dec 5, 2007
Global Feature
A FDA Perspective on Quality by Design
By Patricia Van Arnum
Chi-wan Chen, deputy director of the Office of New Drug Quality Assessment (ONDQA) at the US Food and Drug Administration's Center for Drug Evaluation and Research, shares insight from FDA's pilot program that was designed to allow pharmaceutical companies to submit CMC information demonstrating application of quality by design.
APIs
2007 Ends with a Drought in New Molecular Entities
By Patricia Van Arnum
The number of new molecular entities approved by the US Food and Drug Administration is down this year as the pharmaeutical industry continues to face an innovation drought.
Mergers, acquisitions, and restructuring
2007: The Year in Review
By Patricia Van Arnum
Big Pharma's strategic push into biologics and continuing restructuring are among the highlights for 2007.
Outsourcing
Mixed Message for Contract Manufacturers
By Jim Miller
Candid comments from a Big Pharma executive highlight the complexity of contract manufacturing.

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Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
29%
Breakthrough designations
10%
Protecting the supply chain
43%
Expedited reviews of drug submissions
10%
More stakeholder involvement
10%
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
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