TY - BOOK AU - Mantus,David AU - Pisano,Douglas J. TI - FDA regulatory affairs SN - 9781841849195 (hbk.) PY - 2014/// CY - Boca Raton, FL PB - CRC Press, Taylor & Francis Group KW - Drug Approval KW - United States KW - United States Government Agencies KW - Biological products KW - Standards N1 - Includes bibliographical references and index ER -