Related by context. Frequent words. (Click for all words.) 63 SFDA approval 62 orphan designation 60 Orphan Drug status 60 Marketing Authorization 59 CE Marking 59 PMA submission 59 Orphan Drug Status 59 Biologics License Application 59 Orphan Drug designation 58 Complete Response 58 BLA submission 58 Plenaxis R 58 MONOVISC 58 Biologics License Application BLA 58 Humanitarian Device Exemption 58 supplemental Biologics License Application 57 Trofile 57 Urocidin 57 Hepatitis C HCV 57 FDA Clearance 57 Marketing Authorization Application 57 Investigational Device Exemption 56 BEMA Fentanyl 56 Priority Review 56 IPLEX 56 Veronate 56 FDA approvable letter 56 BENLYSTA 56 IND submission 56 USFDA approval 56 Marketing Authorization Application MAA 56 Loramyc ® 55 Ampligen 55 TearLab 55 cobas 55 Pivotal Phase III 55 TRISENOX 55 Response Biomedical 55 AspenBio 55 Mutual Recognition Procedure 55 Omigard 55 Market Approval PMA 55 NEBIDO 55 vitro diagnostic IVD 55 ISO Certification 55 ATL# [001] 54 FDA Orphan Drug 54 dalbavancin 54 alvimopan 54 registrational 54 ONTAK 54 sBLA 54 Phase III Clinical Trial 54 Uracyst ® 54 GMP certification 54 Virulizin R 54 NuroPro 54 NEUMUNE 54 EOquin 54 registrational trial 54 maribavir 54 Fast Track Designation 54 Investigational Device Exemption IDE 54 Cethrin 54 Mipomersen 54 TH# [003] 54 CHMP opinion 54 PROMACTA 54 orphan medicinal product 53 Rhucin ® 53 BioDelivery Sciences 53 pafuramidine 53 Allovectin 7 R 53 Octreotide 53 dirucotide 53 Retisert 53 ATryn ® 53 Clinical Trial Application 53 prGCD 53 ComfortScan system 53 ROTATEQ 53 ponatinib 53 SUMAVEL DosePro 53 Fast Track designation 53 Onsolis 53 Orphan Drug Designation 53 diagnostic assays 53 StemEx 53 HERmark 53 FIRAZYR 53 Icatibant 53 Exelbine 53 Pharmaxis 53 PREOS 53 MHLW 52 methylnaltrexone 52 phase IIb clinical 52 Pennsaid R 52 Focus Diagnostics 52 INDs 52 GEM #S