Related by context. Frequent words. (Click for all words.) 67 FDA 60 CDRH 59 Drug Evaluation 54 pharmacovigilance 53 REMS 53 DCGI 53 Drug Administration FDA 52 PDUFA 51 MHRA 51 Drug Administration 50 CHMP 50 FDA reviewers 50 NIH 50 European Medicines Agency 49 clinical trials 49 Biologics License Application 49 GSK 49 bioequivalence 48 sNDA 48 Act PDUFA 48 biologics 48 SFDA 48 PDUFA date 48 Priority Review 48 Pharmacovigilance 48 Risk Evaluation 48 Biologics License Application BLA 48 Galson 48 NEJM 47 Bionovo 47 ANDAs 47 Marketing Authorization Application 47 Generic Drugs 47 Cinryze 47 EntreMed 47 Indevus 46 Aspreva 46 clinical trial 46 asenapine 46 Prescription Drug User Fee 46 DHHS 46 Clinical 46 Complete Response Letter 46 New Drug Application 46 Enzon 46 Repros 46 Torisel 46 Biologics Evaluation 46 Treximet 46 Medsafe 46 USFDA 46 Santhera 46 Clolar 46 Trexima 46 NDA submission 46 BENLYSTA 46 Investigational 46 ustekinumab 45 Molecular Insight 45 Arpida 45 EFSA 45 Von Eschenbach 45 ACIP 45 T DM1 45 biosimilar 45 Entereg 45 Somaxon 45 JCVI 45 BioMimetic 45 APhA 45 sBLA 45 Rhucin 45 postmarketing 45 Hollis Eden 45 NovaDel 45 AHPA 44 von Eschenbach 44 Prescribing Information 44 NCI 44 AHRQ 44 Kuvan 44 KineMed 44 ECHA 44 prescribers 44 Actemra 44 vandetanib 44 Clinical Pharmacology 44 Opexa 44 Allos 44 investigational 44 ceftobiprole 44 Pristiq 44 YM BioSciences 44 maraviroc 44 NINDS 44 Neurocrine 44 inVentiv 43 Gene Logic 43 clofarabine 43 ABPI 43 Ligand