000 00563nam a22001697a 4500
005 20260616112023.0
020 _a9781032920542 (pbk)
082 _a615.19
_bFDA
100 _aDavid Mantus (editor)
_aDouglas J. Pisano (editor)
245 _aFDA regulatory affairs
260 _aBoca Raton
_bCRC Press
_c2024
300 _axii, 387 p.
_b: ill.
_c; 23 cm.
500 _aIncludes index.
650 _aPharmacy
_vDrug approval process
_vDrug safety oversight
_vRegulatory compliance
_vRegulatory science
_vPharmaceutical law
_vRIPS
_vGGC
942 _cBK
999 _c59302
_d59302