00309pam a2200121 a 4500020002000000041000800020082001600028100001900044245004600063260003000109300000900139653003900148  a9781841849195c  aeng  a615.19bMAN  aMantus, David.  aFDA Regulatory AffairshTextual Documents  aNew YorkbCRC Pressc2014  a387.  aPharmaceutical/Medicinal Chemistry