FDA Office of Generic Drugs Question-Based Review Initiative: An Update

Publication
Article
Pharmaceutical TechnologyPharmaceutical Technology-06-02-2009
Volume 33
Issue 6

The Question-Based Review (QbR) initiative of the Office of Generic Drugs has reached its second full year in 2009. Special from the Journal of Validation Technology.

This article was published in the Journal of Validation Technology, Spring 2009, Volume 15, Number 2. Authors Aloka Srinivasan and Robert Iser provide an update on the Question-Based Review Initiative by FDA's Office of Generic Drugs. Read about the initiative on gxpandjvt.com.

Articles in this issue
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Quality in, Quality Out
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Quarantine at a Glance
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Drug Serialization and Supply-Chain Security
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Initial Solvent Screening of Carbamazepine, Cimetidine, and Phenylbutazone: Part 2 of 2
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Pharmacosomes: A Potential Alternative to Conventional Vesicular Systems
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Package Design Boosts Patient Compliance
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Truth and Transparency
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Outsourcing Clinical Trial Materials
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Penny-Wise, Pound-Foolish
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Mapping Opportunities for Patent Positions
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Beneath the Surface
Operator Error
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Charting a Pathway to Follow-On Biologics
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In the Spotlight June 2009
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Report From: Ireland
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