Articles by John Smith - Pharmaceutical Technology

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Articles by John Smith

John Smith


John Smith is associate director for regulatory science at the Office of New Drug Quality Assessment in FDA's Center for Drug Evaluation and Research, 10903 New Hampshire Ave., Bldg. 21, Rm. 2630, Silver Spring, MD 20993-0002.

Inside ICH: Quality Trio Takes Final Shape
June 2, 2009

FDA leaders explain the purpose and plan for ICH's three quality guidelines.

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FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
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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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