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1. Title: FDA regulatory affairs / edited by David Mantus, Douglas J. Pisano.
Publication: CRC Press, Taylor & Francis Group, Boca Raton, FL : [2014]
Edition: Third edition.
2. Title: Preparing for FDA pre-approval inspections / edited by Martin D. Hynes, III.
Drugs and the pharmaceutical sciences ;
Publication: Marcel Dekker, New York : c1999.
 
 
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