TY - BOOK AU - Gopalaswamy, Smita AU - Gopalaswamy, Venky AU - Smita Gopalaswamy TI - Combination products : regulatory challenges and successful product development SN - 9781420064469 SN - 200704309 U1 - 615.1 SMI PY - 2008/// CY - Boca Raton, FL PB - CRC Press KW - Biological products - Standards - United States KW - Device Approval - standards - United States KW - Drugs - Standards - United States KW - Equipment and Supplies - standards - United States KW - Equipment Design - standards - United States KW - Medical instruments and apparatus - Standards - United States N1 - Includes bibliographical references and index ER -