TY - BOOK AU - Mantus, David. AU - Pisano, Douglas J. TI - FDA regulatory affairs: a guide for prescription drugs, medical devices, and biologics SN - 1587160072 PY - 2004/// CY - Boca Raton PB - CRC Press KW - Biological Products KW - standards KW - Drug Industry KW - Equipment and Supplies KW - Government Regulation N1 - Includes bibliographical references and index ER -