ePT--the Electronic Newsletter of Pharmaceutical Technology, Sep 29, 2011 - Pharmaceutical Technology

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ePT--the Electronic Newsletter of Pharmaceutical Technology, Sep 29, 2011
News
FDA Publishes Guidance on Marketed Unapproved Drugs
By Erik Greb
FDA has published a guidance on Marketed Unapproved Drugs—Compliance Policy Guide, which describes the agency's enforcement priorities with regard to products that lack regulatory approval or that are not marketed in accordance with the over-the-counter drug review.
New FDA Guidance on User Fee Waivers, Reductions, and Refunds
By Amy Ritter
FDA has issued a guidance titled User Fee Waivers, Reductions and Refunds for Drug and Biological Products that outlines FDA's policies for issuing waivers, refunds or reductions in prescription drug user fees.
EMA Committee Offers Positive Opinion on New Drugs, Moves Forward with Key Concept Papers
By Stephanie Sutton
The latest meeting of the EMA's Committee for Medicinal Products for Human Use has concluded with more than 15 positive opinions for new and generic drugs and the adoption of key concept papers.
Week of Sept. 26, 2011: BMS Collaborates With Ambryx; Merck & Co. Opens New R&D Center; Teva Acquires Joint Venture Interest; and More.
Week of Sept. 26, 2011: BMS collaborates with Ambryx; Merck & Co. opens new R&D center; Teva acquires joint venture interest; and More.

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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
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Reducing drug shortages
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Expedited reviews of drug submissions
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More stakeholder involvement
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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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