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Industry, Regulators Move to Adopt Quality Standards

Harmonization spurs efforts to implement modern manufacturing systems and risk-management programs.
http://www.pharmtech.com/pharmtech/article/articleDetail.jsp?id=400644

The HIT Revolution in Clinical Research

Disciplines such as systems biology, high-throughput screening, bioinformatics, and data visualization are beginning to show promise
http://www.actmagazine.com/appliedclinicaltrials/article/articleDetail.jsp?id=4

Innovations in API Synthesis

As custom manufacturers gather for InformexUSA this month, strategies in asymmetric synthesis and catalysis prevail.
http://www.pharmtech.com/pharmtech/article/articleDetail.jsp?id=400918

New drugs join guidelines for multiple myeloma

Multiple myeloma is the second most common form of hematologic cancer (non-Hodgkin's lymphoma is the first)...
http://www.drugtopics.com/drugtopics/article/articleDetail.jsp?id=398005

New Strategies for the CRO – Sponsor Relationship

Drug developers balance on a knife's edge, trying to formulate innovative new compounds quickly that will survive late-stage clinical trials
http://www.pharmtech.com/pharmtech/article/articleDetail.jsp?id=397031

Drug discovery down, despite quicker approvals

Still, according to Williams, the United States currently leads the world with nearly 3,000 new drugs in development...
http://www.drugtopics.com/drugtopics/article/articleDetail.jsp?id=389599

Pipeline-Rays of Light

This year's Pipeline Report profiles 32 compounds that are the early fruit of pharma's investment in targeted drug design.
http://www.pharmexec.com/pharmexec/article/articleDetail.jsp?id=389274

Therapeutic Equivalence-FDA Approved Drug Products with Therapeutic Equivalence Evaluations

Orange Book
http://www.fda.gov/cder/orange/default.htm

FDA Awards Contract to Assess Postmarketing Study Commitment Decision-Making Process

Analysis Will Lead To a More Standardized Approach
http://www.fda.gov/bbs/topics/NEWS/2006/NEW01350.html

FDA Unveils Critical Path Opportunities List Outlining Blueprint To Modernizing Medical Product Development by 2010

Biomarker Development and Clinical Trial Design Greatest Areas for Impact
http://www.fda.gov/bbs/topics/news/2006/NEW01336.html
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Search returned 44 items.
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