Related by context. Frequent words. (Click for all words.) 64 Welfare MHLW 58 Swissmedic 56 DCGI 56 Marketing Authorization 55 orphan designation 54 Shionogi 54 Abstral 54 Sosei 53 India DCGI 53 Act PDUFA date 53 Mitsubishi Pharma 52 Marketing Authorization Application MAA 52 BEMA Fentanyl 52 Mutual Recognition Procedure 52 New Drug Application 52 Marketing Authorization Application 52 European Medicines Evaluation 52 Orphan Drug status 52 USFDA 52 Competent Authority 52 CE Marking 52 SFDA approval 51 FDA 51 pediatric exclusivity 51 Sancuso 51 NOXAFIL 51 sBLA 51 KFDA 51 Orphan Drug 51 PREOS 51 Chugai 51 Orphan Drug designation 51 Sankyo 51 Drug Administration FDA 50 CHMP opinion 50 Oral Solution 50 SFDA 50 Complete Response 50 Ono Pharmaceutical 50 European Medicines Agency 50 Onsolis 50 Eisai 50 Kamada 50 Biologics License Application 50 JFTC 50 sNDA 50 ELAPRASE 50 orphan medicinal product 50 Toctino ® 50 ONSOLIS 49 Otsuka Pharmaceutical 49 alogliptin 49 Chugai Pharmaceutical Co. 49 Dainippon Sumitomo Pharma 49 Peramivir 49 CDER 49 Takeda 49 pancreatic enzyme 49 Satraplatin 49 Orexo 49 Biologics License Application BLA 49 Icatibant 49 orphan drug 49 PDUFA date 49 INDs 48 Sucampo 48 Investigational Device Exemption 48 Medsafe 48 Omnitrope 48 OFIRMEV 48 Drug Application 48 Relistor 48 Therapeutic Products 48 Phenoptin 48 Scientific Advice 48 BLA submission 48 taliglucerase alfa 48 LIALDA 48 Loramyc ® 48 Fast Track Designation 48 Daiichi Sankyo 47 Janssen Pharmaceutical 47 voclosporin 47 Drug Controller 47 Pivotal Phase III 47 lubiprostone 47 Drugs Controller 47 REPLAGAL 47 Citizen Petition 47 PEG INTRON 47 methylnaltrexone 47 ThermoDox ® 47 Mitsubishi Tanabe Pharma 47 CHMP 47 satraplatin 47 Tokyo JCNN 47 Drug Administration USFDA 47 silodosin 47 Orphan Drug Designation 47 alvimopan 47 Avastin bevacizumab