RichaTrivedi16

risk based classification definition pre market about ghtf study group 1 ghtf usfda guideline premarket approva meaning premarket notification special control general control of ivd diffrence between both pma types of ivd examples of ivd denovo classifcation ivd usfda regulation premarket approval application form for biologic biologics in india selection of biologics principle of biologic examples of biologics asmf content filing types of dmf dmf content dmf filing review pathway hatchwaxman act patent filing regulatory affairs anda