000 01424cam a22003618a 4500
001 920222
003 OCoLC
005 20210921174747.0
008 030217s2003 flu 000 0 eng
020 _a1587160072
020 _a9781587160073 :
_c£32.99
040 _aUKM
_cUKM
_dOCLCQ
043 _an-us---
082 0 4 _a615.190973
_bPIS
100 1 _aPisano, Douglas J.
_938605
245 1 0 _aFDA regulatory affairs :
_ba guide for prescription drugs, medical devices and biologics /
260 _aBoca Raton, Fla. ;
_aLondon :
_bCRC,
_c2003.
300 _a250 p. ;
_c23 cm.
336 _atext
_2rdacontent
337 _aunmediated
_2rdamedia
338 _avolume
_2rdacarrier
520 8 _aThis text covers the regulatory requirements of pharmaceuticals, biologics, and medical devices. It examines the pertinent aspects of the Federal Food, Drug and Cosmetic Act as it applies to human drug and device development, research, manufacturing, and marketing.
610 1 0 _aUnited States.
_bFood and Drug Administration
_vRules and practice.
650 0 _aDrugs
_zUnited States
_xTesting.
650 0 _aDrug development
_zUnited States.
650 0 _aPharmaceutical industry
_zUnited States.
650 0 _aMedical instruments and apparatus
_zUnited States.
902 _a161214
907 _a.b10436303
_bmulti
_c-
942 _n0
948 _hNO HOLDINGS IN LQI - 1 OTHER HOLDINGS
998 _b0
_c050117
_dm
_ea
_g0
999 _c41592
_d41592