Related by context. Frequent words. (Click for all words.) 64 Act PDUFA date 63 PDUFA 63 Act PDUFA 58 Prescription Drug User Fee 56 PDUFA date 56 FDA Advisory Panel 54 FDA Accepts 54 MHLW 54 dalbavancin 53 MIPPA 53 IND submission 53 FDA 52 Cladribine 52 Anthim 52 Generic Version 52 Research CDER 51 Project BioShield Act 51 TYGACIL 51 application sNDA 51 PMA submission 51 Drug Administration FDA 51 generic biologic 51 CDER 51 pediatric exclusivity 51 Physician Payment 50 Phase III Clinical Trial 50 Cethromycin 50 Octreotide 50 GPhA 50 Biosimilars 50 FDA approvable letter 50 Drug Application 49 BLA submission 49 NeutroSpec 49 Afluria 49 Oral Solution 49 QNEXA 49 Plenaxis R 49 Angiox 49 Hatch Waxman 49 PRISTIQ 49 Mutual Recognition Procedure 49 BioDelivery Sciences 48 Swissmedic 48 LIALDA 48 NEBIDO 48 Emend 48 Intuniv 48 Biologics License Application BLA 48 Oncologic Drugs Advisory 48 Priority Review 48 Pirfenidone 48 Focalin XR 48 Investigational Device Exemption 48 VALSTAR 48 Icatibant 48 NOXAFIL 48 Market Approval PMA 48 ATryn ® 48 Citizen Petition 48 Gestiva 48 FDA Orphan Drug 48 Onsolis 47 Drug Administration 47 ezogabine 47 Complete Response 47 supplemental Biologics License Application 47 approvability 47 REMS 47 Marketing Authorization 47 Program Reauthorization Act 47 Solzira 47 Complies 47 PMAs 47 Hatch Waxman Act 47 Patient Enrollment 47 Pharmacopeia USP 47 ISTODAX 47 Phase III Trial 47 Pennsaid R 46 orphan designation 46 Treximet 46 Exalgo 46 alvimopan 46 Rhucin ® 46 SCHWARZ PHARMA 46 Approval Process 46 Ceftobiprole 46 Cervical Cancer Vaccine 46 Telavancin 46 Sensipar 46 Caduet 46 PhosLo 46 Neurodex 46 Mitigation Strategy 46 Vilazodone 46 Pivotal Phase III 46 Health HITECH Act 46 Prescribing Information 46 PL #-# [001] 46 FIRAZYR