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(Click for frequent words.) 78 Act PDUFA 73 PDUFA 71 Act PDUFA date 65 PDUFA Prescription Drug 65 PDUFA date 59 Priority Review 58 User Fee Act 56 Drug Administration Amendments 55 FDAAA 55 FDA Modernization Act 54 supplemental Biologics License Application 53 pediatric exclusivity 53 Accelerated Approval 52 assigned PDUFA 52 Complete Response 51 Voraxaze 51 Project BioShield Act 51 Biologics License Application BLA 51 PDUFA Date 51 Drug User Fee 51 Intermezzo ® NDA 51 Hatch Waxman 51 Specialty Crop Competitiveness 51 MDUFMA 51 BRILINTA 50 eprodisate Fibrillex TM 50 SEASONIQUE 50 Biologics License Application 50 Biologic License Application BLA 50 Combat Methamphetamine Epidemic 50 Arzerra ofatumumab 49 Biologic License Application 49 alogliptin 49 application sNDA 49 Nonprescription Drug Consumer 49 Biologics Licensing 49 Application BLA 49 CERVARIX R 49 Telavancin 49 Muraglitazar 49 NASA Authorization 49 nasal calcitonin product 48 Fast Track designations 48 Subpart E 48 sNDA 48 Dexilant 48 Expedited Review 48 peginesatide 48 dalbavancin 48 NDA resubmission 48 Anti Infective Drugs 48 Hatch Waxman Act 48 Subpart H 48 supplemental biologics 48 FDA approvable letter 48 European Medicines Evaluation 48 NUVIGIL 48 FDA Oncologic Drugs 48 telavancin NDA 48 ONGLYZA ™ 48 Federal Torts Claim 47 generic biologic 47 Orathecin 47 cGMPs 47 Provenge prostate cancer 47 FDA Complete Response 47 ZEGERID Chewable Tablets 47 naproxen esomeprazole magnesium 47 Exalgo 47 Reduce Unnecessary Spending 47 ISO Vorin TM 47 WHO prequalification 47 sBLA 47 BLA filing 47 markets HP Acthar 47 orphan designation 47 FDA 47 MAA submission 47 ezogabine 47 OLEPTRO 47 Alogliptin 47 Zenpep 47 biosimilar 47 Newborn Screening Saves Lives 47 INTUNIV TM guanfacine extended 47 Clolar 47 metoprolol succinate 47 FDA Accepts 47 Vandetanib 47 Physician Payments Sunshine 47 ixabepilone 47 Drug Administration FDA 47 MEND CABG II 47 CIP TRAMADOL ER 47 Stavzor 47 Somatuline Depot 47 Surface Transportation Authorization 47 BLA submission 47 oral ridaforolimus 47 injectable formulations 47 Fast Track designation 46 Gestiva TM 46 Cladribine 46 MK #B 46 darbepoetin alfa Aranesp 46 CDER 46 M Enoxaparin 46 Marketing Authorisation 46 Omnibus Budget Reconciliation 46 Marketing Authorization Application 46 Patient Self Determination 46 Antitrust Improvement 46 highly purified pasteurized 46 ATryn ® 46 REMS 46 HCl capsules 46 granted Ortec 46 Paragraph IV 46 Civacir 46 Biologics License Applications 46 ARCOXIA 46 ISTODAX 46 Ixempra 46 Risperidone Oral Solution 46 MHLW 46 Zarnestra 46 Barr ANDA 46 Mitigation Strategy REMS 46 Research CBER 46 Oncologic Drugs Advisory 46 Fortical R 46 FACTIVE R gemifloxacin 46 FDA Approvable Letter 46 relapsed MCL 46 Receives Tentative FDA 46 PMPRB 46 Premarket Approval 46 TNF blocker 46 lorcaserin NDA 46 Liprotamase 46 sNDA submission 46 Ramelteon 46 Complete Response letter 46 Alvesco R 46 pseudobulbar affect PBA 46 submitted Biologics License 45 CHMP recommendation 45 Habeas Corpus Restoration 45 Zolpimist 45 COLAZAL 45 ZEGERID Capsules 45 Unemployment Compensation Extension 45 RANK Ligand inhibitor 45 Orphan Drug status 45 approvable letters 45 Lumizyme 45 Ticagrelor 45 Nebido 45 autologous cellular immunotherapy 45 nanofiltered plasma derived 45 Emend 45 America COMPETES Reauthorization 45 Complete Response Letter CRL 45 Aloxi Injection 45 OraTest 45 mesylate tablets 45 Somatuline R Autogel R 45 Dacogen injection 45 Radioactive Import Deterrence 45 Sanctura XR 45 Marketing Authorisation Application 45 alvimopan 45 albinterferon alfa 2b 45 NOXAFIL 45 Gestiva ™ 45 Faster FOIA 45 APF# NDA 45 Firazyr 45 FDA Endocrinologic 45 NEBIDO 45 Vitrasert R 45 Surfaxin LS 45 RIGScan CR 45 Gamunex C 45 ATryn R 45 Cethromycin 45 fluvoxamine maleate 45 Complete Response Letter 45 Orphan Status 45 TAXUS Element Stent System 45 Velcade bortezomib 45 VitiGam 45 SURFAXIN 45 indiplon capsules 45 Plicera 45 etravirine 45 submit Biologics License 45 FOLOTYN ® 45 postapproval 45 EMBEDA ™ 45 Orphan Drug designations 45 Actemra tocilizumab 45 Neuromodulation System 45 DORIBAX 45 Diesel Emission Reduction 45 Orphan Drug designation 45 PROTECT IP 45 New Drug Application 45 Focalin XR R 45 PIX# trial 45 R sipuleucel T 45 AstraZeneca Symbicort 44 clopidogrel bisulfate 44 Auxilium Pharma 44 Pre IND 44 orphan medicinal product 44 sNDAs 44 Frova ® 44 Arzerra 44 Carbidopa Levodopa 44 mesylate tablets approved 44 Mylan Receives Approval 44 Velaglucerase Alfa 44 ketolide antibiotic 44 NitroMist TM 44 Xolegel 44 Food Allergen Labeling 44 NOPR 44 Genzyme Myozyme 44 vapreotide acetate 44 BENLYSTA ® 44 Bazedoxifene 44 Biosimilars 44 Drug Eluting Stent System 44 QbD 44 quetiapine fumarate 44 Emezine 44 rolling Biologics License 44 Standards CFATS 44 DepoDur TM 44 Horizant 44 CLIA Clinical 44 MHPAEA 44 URG# 44 Viviant 44 Medicinal Products EMEA 44 Receives Approvable Letter 44 Urocidin TM 44 Zegerid OTC 44 Premarket Approval Application 44 Dalbavancin 44 Application MAA 44 ZEGERID Powder 44 DRUG ADMINISTRATION 44 Pixuvri 44 Sprycel dasatinib 44 LymphoStat B TM 44 NDA submission 44 Project Bioshield 44 postmarketing studies 44 Silenor NDA 44 gave Makena orphan 44 Government Paperwork Elimination 44 metformin HCl 44 Sumatriptan Succinate 44 PLAVIX ® 44 Marketing Authorization Application MAA 44 diarrhea predominant irritable 44 authority Gurian Sherman 44 ENRICH trial 44 Esbriet ® 44 investigational compound 44 TYGACIL 44 Zyflo CR 44 ANDA filings 44 Anidulafungin 44 Noxafil 44 Nuedexta 44 IND submission 44 DYSPORT TM 44 Multiple Peril Insurance 44 Pulmonary Allergy Drugs 44 PRECISE Trial 44 See BioWorld Today 44 Kapidex 44 Targretin capsules 44 sNDA filing 44 Vidaza azacitidine 44 Dificid 44 VALSTAR 44 ONSOLIS 44 T Pred 44 Rhucin ® recombinant 44 Orapred ODT 44 Prostate AdenoCarcinoma Treatment 44 ER oxymorphone hydrochloride 44 novel oral anticoagulant 44 Zalbin 44 ENTEREG ® 44 Soliris TM eculizumab 44 Loceryl ® 44 Zirgan 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thresholds 43 Industrial Hemp Farming 43 Riluzole 43 ENLIGHT 43 pregabalin Lyrica 43 ORENCIA ® 43 Frova R 43 HepaGam B 43 AdreView 43 Supplemental Biologics License Application 43 SUPPRELIN R LA 43 AIMM trial 43 ACIPHEX 43 anidulafungin 43 Title XVII 43 ADAAA 43 capsules USP 43 Biological Weapons Anti Terrorism 43 5mg #mg #mg 43 Omapro 43 Krystexxa 43 ALVESCO R 43 Aplenzin 43 TEWI actions 43 OMP designation 43 DPX Survivac 43 Medicinal Products 43 PMA Supplement 43 omeprazole sodium bicarbonate 43 UCB Cimzia 43 Nonviolent Offender Rehabilitation 43 SILENOR 43 Zytiga 43 FDA Antiviral Drugs 43 Kynapid 43 LibiGel NDA 43 Marketing Authorisation Application MAA 43 Metabolic Drugs Advisory 43 Lifespan Respite Care 43 Cellegesic 43 Eli Lilly Cymbalta 43 Febuxostat 43 Child Nutrition Reauthorization 43 Cesamet 43 Cand5 42 Orexigen Contrave 42 Generic Version Of 42 CryoSeal FS System 42 Pirfenidone 42 Drug Submission 42 LEUKINE 42 DEXILANT 42 Development OOPD 42 Zolinza 42 methylnaltrexone 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NASDAQ HITK 42 Stalevo ® 42 Rasagiline 42 ATPace TM 42 Dementia Related Psychosis 42 Ropinirole 42 Everglades Forever 42 granulated mesalamine 42 Uplyso 42 Lipofen 42 ACUROX ® 42 ANDAs 42 Psychopharmacologic Drugs Advisory 42 equivalent Reglan 42 NeutroSpec 42 reapproval 42 lucinactant 42 rilonacept 42 Investigational Device Exemption 42 Precious Metals Marking 42 eprodisate KIACTA TM 42 TWYNSTA ® 42 Treximet 42 postmarket surveillance 42 Dendreon Provenge 42 sublingual tablets 42 National Coverage Determination 42 DPP4 inhibitor 42 pancreatic enzyme replacement 42 Oracea R 42 Tekturna HCT ® 42 SYCREST 42 prGCD 42 Nasdaq SPPI 42 VIMOVO 42 Plenaxis R 42 GENTAMICIN SURGICAL IMPLANT 42 Zensana 42 Alitretinoin 42 PMA submission 42 Toxic Chemicals Safety 42 NerPharMa 42 Scottsboro Boys Sister 42 ISENTRESS raltegravir 42 Children VFC 42 Drug Administration Oncologic Drugs 42 UCB Keppra 42 approvability 42 Annual Required Filings 42 Cefazolin 42 GRAS notification 42 Pentacel vaccine 42 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