Articles by David J. Skanchy - Pharmaceutical Technology

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Articles by David J. Skanchy

David J. Skanchy


David J. Skanchy, PhD, is a review chemist with the US Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, tel. 240.276.8552, fax 240.276.8582.

Question-Based Review: An FDA Reviewer's Perspective
October 2, 2009

The author analyzes, from an agency perspective, whether question-based review has improved product quality or made the review process easier for regulators or for industry.

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