FDA regulatory affairs / 
edited by David Mantus, Douglas J. Pisano 
 - 3rd ed. 
 - Boca Raton, FL :  CRC Press, Taylor & Francis Group,  2014 
 - xii, 387 p. ;  24 cm. 
<br/><br/>Includes bibliographical references and index 
<br/><br/><label>ISBN: </label>9781841849195 (hbk.) 
<br/><br/><label>Subjects--Topical Terms: </label><br/>Drug Approval--United States<br/>United States Government Agencies--United States<br/>Biological products--Standards--United States