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
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerTargeting Different Off-Shore Destinations
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAsymmetric Synthesis Continues to Advance
Jill Wechsler Regulatory Watch Jill Wechsler Data Integrity Key to GMP Compliance
Sean Milmo European Regulatory WatchSean MilmoExtending the Scope of Pharmacovigilance Comes at a Price
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