FDA regulatory affairs:  a guide for prescription drugs, medical devices, and biologics/ 
edited by Douglas J. Pisano, David Mantus. 
 - Boca Raton:  CRC Press,  c2004. 
 - 360 p.:  ill.;  24 cm. 
<br/><br/>Includes bibliographical references and index. 
<br/><br/><label>ISBN: </label>1587160072 9781587160073 
<br/><br/><label>Subjects--Topical Terms: </label><br/>Biological Products--standards<br/>Drug Industry--standards<br/>Equipment and Supplies--standards<br/>Government Regulation