Related by context. Frequent words. (Click for all words.) 63 Risk Evaluation 57 Medication Guide 53 prescribers 53 CDER 51 pharmacovigilance 51 Exalgo 50 FENTORA 50 PDUFA 49 PDUFA date 49 Horizant 48 Entereg 48 ONSOLIS 48 Treximet 48 FDA 48 Biosimilars 48 ISENTRESS 48 NDA submission 47 Priority Review 47 Trexima 47 ADDERALL XR 47 ESAs 47 Act PDUFA 46 biogenerics 46 Torisel 46 Prescription Drug User Fee 46 APhA 46 Seroquel XR 46 Prescribing Information 46 biosimilar 46 Keflex 46 ENTEREG 46 formulary 46 postmarketing 45 PhosLo 45 Afrezza 45 Xifaxan 45 CDRH 45 Ranexa 45 Symlin 45 ustekinumab 45 Biologics License Application BLA 45 Acurox 45 biogeneric 45 Bydureon 44 CHMP 44 full Prescribing Information 44 Fentora 44 European Medicines Evaluation 44 Contrave 44 FDA reviewers 44 medication adherence 44 ePrescribing 43 Xolair 43 motavizumab 43 Comparative Effectiveness Research 43 Xarelto 43 FACTIVE 43 Cinryze 43 Foradil 43 Victoza 43 pediatric exclusivity 43 MOXATAG 43 sNDA 43 alogliptin 42 REACH 42 PQRI 42 clinical endpoints 42 ZEGERID 42 Effient 42 prescribing 42 Qutenza 42 Oncology Drug 42 Clolar 42 medications 42 Medicare Modernization Act 42 Galvus 42 bioequivalent 42 ANDAs 42 guidances 42 ISPE 41 JCAHO 41 prescriber 41 Lumizyme 41 Mylotarg 41 formularies 41 Elidel 41 liver toxicity 41 Complete Response Letter 41 Pristiq 41 Actemra 41 Generic Drug 41 GMPs 41 Glumetza 41 NDAs 41 Rimonabant 41 approvable 41 approvable letter 40 Drug Administration FDA 40 Cleviprex 40 e Prescribing 40 Esbriet