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(Click for frequent words.) 84 Drug Administration 79 Drug Administration FDA 69 Drug Adminstration 69 F.D.A. 67 CDER 66 USFDA 66 CDRH 63 FDAs 61 Drug Administration USFDA 61 approvable letters 60 FDA reviewers 60 Drug Administration Oncologic Drugs 60 DCGI 60 FDA Advisory Panel 59 DrugAdministration 59 postmarket surveillance 58 European Medicines Agency 58 Subpart H 58 FTC 57 Drug Administrations 57 SFDA 57 Drug Administration KFDA 56 von Eschenbach 56 DDMAC 56 Botox Botox Cosmetic 56 PDUFA 56 Communications DDMAC 56 Actavis Totowa 56 CFSAN 56 Lilly Cymbalta 56 GSK Avandia 56 Dr. Pazdur 56 FSANZ 56 premarket notification 55 Therapeutic Goods Administration 55 FDA Oncologic Drugs 55 USDA FSIS 55 OHRP 55 postapproval 55 Drug Administration www.fda.gov 55 Galson 55 FDA approvable letter 55 authority Gurian Sherman 55 Lorqess 55 dalbavancin 55 FDAâ € ™ 55 ProHeart 6 55 Replagal 55 generic Lovenox 54 CHMP 54 Voraxaze 54 cGMPs 54 Kynapid 54 Drug Adminstration FDA 54 carbinoxamine 54 postmarketing surveillance 54 FSIS 54 EFSA 54 Nebido 54 CDER FDA 54 Ketek 54 Regranex 54 Afrezza 54 Horizant 54 gadobutrol 54 heparin vials 54 Complete Response 54 Xinlay 54 Amylin Byetta 54 midodrine 53 Doribax 53 Menaflex device 53 DrugAdministration FDA 53 Pulminiq 53 FDAAA 53 Devices Advisory Panel 53 Zenpep 53 Warning Letter 53 TGA 53 SURFAXIN 53 Certriad 53 Drug Administration Amendments 53 FDA Modernization Act 53 Citizen Petition 53 approvability 53 Not Approvable 53 pulls Darvon painkiller 53 India DCGI 53 Amphastar 53 Orexigen Contrave 53 ImClone Erbitux 53 Pulmonary Allergy Drugs 53 Onsolis 53 Metabolic Drugs Advisory 53 Visicol 53 Thyrogen 53 FDA Complete Response 53 MDUFMA 53 CPSC 53 MHRA 53 Laura Alvey 53 Darvon Darvocet 53 FDA Adverse Event 53 Potiga 53 Oncologic Drugs Advisory 53 Premarket Approval 53 Pristiq 53 User Fee Act 53 Altabax 53 Azathioprine 53 propoxyphene containing 53 generic biologic 53 Research CDER 53 PDUFA Date 52 AquAdvantage Salmon 52 Susan Bro 52 Afresa 52 Ofirmev 52 overthe counter 52 FDA Approvable Letter 52 Relistor 52 Linjeta 52 multidose vials 52 balsalazide tablet 52 Research CBER 52 Tredaptive 52 Enjuvia 52 Krystexxa 52 Drug Administration FDA Oncologic 52 ATryn 52 European Medicines Evaluation 52 CHMP recommendation 52 Menaflex implant 52 Chemical Toxicology 52 Velac 52 Entereg 52 Vivus Qnexa 52 Glaxo Avandia 52 CERVARIX R 52 Omnitrope 52 Palladone 52 Orapred ODT 52 Medsafe 52 Trexima 52 maker Barr Pharmaceuticals 52 Orathecin 52 Serevent 52 Fusilev 52 MyVax 52 Medtronic stent 52 Propulsid 52 Tygacil 52 Avastin bevacizumab 52 Zyflo CR 52 Viviant 52 NeutroSpec 52 Novartis Galvus 52 Emend 51 Praecis 51 Biologics Licensing 51 Swissmedic 51 GRAS status 51 Drug Administration FDA Endocrinologic 51 MHLW 51 Von Eschenbach 51 postmarket studies 51 Uloric 51 liver resection surgeries 51 Zicam Cold Remedy Swabs 51 Paragraph IV Notice 51 OsmoPrep 51 Glaxo Cervarix 51 Fablyn 51 Inamed silicone implants 51 T Pred 51 Symlin 51 WHO prequalification 51 NIH 51 GPhA 51 Propoxyphene 51 Cefazolin 51 Xifaxan 51 Cladribine 51 #k Clearance 51 Sparlon 51 antidepressant Serzone 51 Janet Woodcock 51 FDA Psychopharmacologic Drugs 51 FDA Endocrinologic 51 postmarketing studies 51 Kombiglyze XR 51 oral sodium phosphate 51 Dexilant 51 Saphris 51 clinical trials 51 FACTIVE R gemifloxacin 51 Shuren 51 Genzyme Myozyme 51 Drug Submission 51 Nonprescription 51 Anti Infective Drugs 51 Merck Arcoxia 51 Dendreon Provenge 51 lorcaserin NDA 51 AstraZeneca Iressa 51 Combating Counterfeit Drugs 51 Fentora 51 SPARLON 51 Drug Administration MedWatch 51 recombinant thrombin 51 fda 51 Bydureon 51 Tylenol Motrin Benadryl 51 darbepoetin alfa Aranesp 51 FDA Antiviral Drugs 51 Sanctura XR 51 FDA Approval 51 Novartis AG Galvus 51 anidulafungin 51 Exanta 51 Lumizyme 51 Mitigation Strategies REMS 51 PhosLo 51 Provenge prostate cancer 51 GlaxoSmithKline Plc diabetes 50 Bristol Myers Squibb Abilify 50 Arranon 50 SEASONALE 50 spokeswoman Lenore Gelb 50 Genetically Modified Salmon 50 Protopic 50 Biegelsen 50 Zelnorm 50 Mylotarg 50 Intelence 50 Cellegesic 50 Risperidone Oral Solution 50 BRILINTA 50 Pfizer inhaled insulin 50 KFDA 50 BioDelivery 50 Genetic Therapies Directorate 50 unapproved hydrocodone 50 Glaxo rotavirus vaccine 50 injectable formulations 50 Ramelteon 50 mesylate tablets approved 50 blood thinner prasugrel 50 allergen labeling 50 Fortical R 50 Pfizer Exubera 50 Glaxo 50 DSHEA 50 GSK 50 Novartis Prexige 50 Tyvaso 50 Sanofi Aventis Acomplia 50 Novartis AG Foradil 50 PMA submission 50 Intermezzo ® NDA 50 Mitigation Strategy REMS 50 Stonewall BDL 50 Merck Gardasil 50 PDUFA date 50 Stavzor 50 DNAwithPap TM Test 50 BioDelivery Sciences 50 Amgen Prolia 50 APF# NDA 50 Accelerated Approval 50 OLEPTRO 50 Prexige 50 Taxus Liberte 50 domperidone 50 USDA 50 vaccine RotaTeq 50 motavizumab 50 Pharmacopeia USP 50 clinical trial 50 Avandia rosiglitazone 50 Therapeutic Goods Administration TGA 50 CryoSeal FS System 50 COX 2s 50 ONSOLIS 50 alogliptin 50 FDA Circulatory System 50 Administration TGA 50 QbD 50 Mucotrol 50 OvaDx 50 Roxane Laboratories 50 Biologic License Application 50 Zensana 50 Exalgo 50 Expanded Indication 50 ANDA filings 50 Merck Januvia 50 Nuedexta 50 Ariva BDL 50 BioMimetic 50 Marketing Authorisation Application 50 USPTO 50 AstraZeneca Brilinta 50 Zyflo 50 liprotamase 50 postmarket 50 pill Contrave 50 Bifeprunox 50 liver toxicity 50 Celebrex celecoxib 50 genetically engineered salmon 50 Xarelto rivaroxaban 50 Metozolv ODT 50 Prexige lumiracoxib 50 Biosante 50 Surfaxin lucinactant 50 Tequin 50 Approvable 50 PREVU x POC 50 Metformin Hydrochloride 50 pediatric exclusivity 50 NDA resubmission 50 Zytiga 50 Icatibant 50 ONGLYZA ™ 49 Vertex hepatitis C 49 mg canada 49 Novo Nordisk Victoza 49 Hycamtin 49 granted Ortec 49 Ranexa 49 Myfortic 49 approvable letter 49 mg usa 49 Aptivus 49 Biologics License Application 49 EPA 49 Xanodyne 49 biogeneric drugs 49 PMPRB 49 Estratest 49 equivalent Reglan 49 Liprotamase 49 Acurox 49 Galida 49 GMPs 49 Therapeutics Bulletin DTB 49 Asclera 49 multiple dose vials 49 Noxafil 49 Auxilium Pharma 49 Amgen Aranesp 49 Gralise 49 Randall Lutter 49 Barr ANDA 49 Fortesta 49 Promacta 49 Adcirca 49 Zalbin 49 ANDA applicant 49 Acomplia rimonabant 49 Safety Authority EFSA 49 Sotret 49 Kiacta 49 self affirmed GRAS 49 metoprolol succinate 49 Amgen Nplate 49 Bextra painkiller 49 Xyotax 49 PMA Supplement 49 LensAR Laser System 49 Zemplar 49 Pre IND 49 CHMP opinion 49 molecular entities NMEs 49 Toctino ® alitretinoin 49 Reclast Aclasta 49 postmarketing 49 SILENOR 49 withdrew Baycol 49 Act PDUFA 49 AMAG 49 Gilenia 49 requiring Asthmatx 49 injectable heparin 49 Byetta 49 Symbyax 49 Dr. Badrul Chowdhury 49 Effient 49 Benlysta 49 Pixuvri 49 KV Pharmaceuticals 49 Emezine 49 Sunovion 49 Avandamet tablets 49 biogeneric 49 painkiller Prexige 49 Auralgan 49 topical NSAID 49 Darvon painkiller 49 drug eluting coronary stents 49 Vivus 49 PDUFA Prescription Drug 49 CGMP 49 OraTest 49 AVANDIA 49 METOZOLV ODT 49 Clolar 49 JECFA 49 Lilly Evista 49 Orphan Status 49 testosterone gel LibiGel 49 Asmanex 49 GRAS affirmation 49 supplemental biologics 49 Vioxx Celebrex 49 Avandia 49 Amgen Vectibix 49 Indiplon 49 Paragraph IV 49 Devicemakers 49 antibiotic Ketek 49 RotaShield 49 levothyroxine sodium 49 AdreView 49 Anchen Pharmaceuticals Inc. 49 CigRx TM 49 Xifaxan rifaximin 49 SPIRIVA HandiHaler 49 spokesman Doug Arbesfeld 49 postmarket safety 49 ustekinumab 49 Cesamet 49 Bepreve 49 Dr. Kate Gelperin 49 Fluarix vaccine 49 Establishment Inspection 49 Drug Application 49 Receives Tentative FDA 49 Drug Administration Modernization Act 49 Fosrenol 49 GlaxoSmithKline Plc Avandia 49 exenatide Byetta 49 ZEGERID Chewable Tablets 49 Johann Liang 49 Adventrx 49 Rotarix ® 49 approvable 49 Treximet 49 Rotarix vaccine 49 Genentech Raptiva 49 Vimovo 49 Regulatory Authority MHRA 49 Cancidas 49 Amyvid 49 rotavirus vaccine Rotarix 49 Egrifta 49 FDA Accepts 49 Lotronex 49 Invirase 49 Encysive Pharmaceuticals Nasdaq ENCY 49 Velcade bortezomib 48 Susan Cruzan 48 investigational 48 HCl capsules 48 Cinryze 48 hypersensitivity allergic reactions 48 Contrave 48 Elidel 48 antibiotic Cubicin 48 HPV vaccine Cervarix 48 eczema creams 48 Spiriva HandiHaler 48 alvimopan 48 Nabi HB Intravenous 48 UCB Keppra 48 Contaminated Heparin 48 Drug Evaluation 48 Orexigen 48 Drugs Advisory 48 Elan Tysabri 48 Human Genome lupus 48 Vilazodone 48 Accolate 48 Telavancin 48 LDTs 48 Arxxant 48 Vimpat R 48 Mark Senak 48 injectable gel 48 ICH E# 48 Morphine Sulfate 48 Sanofi Acomplia 48 Aveed 48 Transkaryotic 48 Optison 48 Injectafer 48 Drug Administration anidulafungin 48 SANVAR 48 Generic Version Of 48 Myozyme 48 Victoza 48 Frova 48 NMEs 48 Bextra 48 Evicel 48 ETHEX 48 ulipristal acetate 48 HepaGam B 48 FDA GRAS 48 Hylenex 48 Oral Solution 48 FDA Nonprescription Drugs 48 Exelbine NDA 48 bazedoxifene 48 NDA submission 48 biopharming 48 Complete Response Letter CRL 48 Armour Thyroid 48 bloodthinner 48 Metformin GR 48 Dal Pan 48 EXALGO 48 Levothyroxine Sodium 48 Civacir 48 Marketing Authorization 48 Atryn 48 OTC Mevacor 48 Riluzole 48 Pat El Hinnawy 48 Removab 48 Spiriva Handihaler 48 mg uk 48 Bridion 48 Merck Vioxx 48 orphan medicinal 48 AFSSAPS 48 ANDAs 48 Hexvix 48 k Premarket Notification 48 Complete Response letter 48 Kaletra tablet 48 Avanir 48 Danco Laboratories 48 Boxed Warning 48 Optimark 48 CFIA 48 rhThrombin 48 ULTRASE 48 Daliresp 48 Glycopyrrolate 48 Muraglitazar 48 Pharmacopeial USP Convention 48 Actemra 48 AZILECT R 48 Akabani 48 Cubicin 48 Avandia Actos 48 Dr. Jeffrey Shuren 48 Recothrom 48 NitroMist 48 Diastat 48 Goozner 48 Galvus 48 MAA submission 48 Siobhan DeLancey 48 PDUFA reauthorization 48 REMS 48 Dermacyn Wound Care 48 Nonprescription Drugs 48 Neupro 48 Lilly Zyprexa 48 Board DSMB 48 BFAD 48 Biologic License Application BLA 48 Natroba 48 FDA Anti Infective 48 ephedra supplements 48 eMDR 48 Myobloc 48 TWYNSTA ® 48 Dificid 48 silicone gel filled 48 Irinotecan Hydrochloride Injection 48 UCB Cimzia 48 prefilled syringe 48 Biologics License Application BLA 48 Tussionex 48 CIP Fenofibrate 48 PREVU x LT 48 AQSIQ 48 Foradil 48 Oxytrol 48 FALCPA 48 estriol 48 Cethromycin 48 biosimilar 48 Toprol 48 AIR inhaled insulin 48 Rita Chappelle 48 Focalin XR 48 Alimta pemetrexed 48 Shelhigh 48 Xarelto 48 NeoProfen 48 FOSAMAX PLUS D 48 Cenestin 48 LUVOX CR 48 inspectional observations 48 LibiGel ® 48 Safety Authority NZFSA 48 Salix Pharma 48 USFDA approval 48 CONBRIZA 48 Invega Sustenna 48 Tysabri natalizumab 48 AstraZeneca Symbicort 48 Zicam Cold Remedy Gel 48 Merck RotaTeq 48 Amoxicillin Pulsys 48 Rasagiline 48 Invega 48 Increlex 48 Enteryx 48 Iovate 48 NerPharMa 48 Nonprescription Products 48 Application BLA 48 painkiller Celebrex 48 Medwatch 48 Byetta LAR 48 McNeil Pediatrics 48 Montelukast 48 Zegerid OTC 48 Postmarket 48 Dostinex 48 Frova R 48 varenicline tartrate 48 BLA filing 48 IV acetaminophen 48 Amevive 48 Eli Lilly Zyprexa 48 Metabolic Drugs 48 Drug Administration SFDA 48 Xgeva 48 Receives Approvable Letter 48 Tysabri 48 Sharfstein 48 Bazedoxifene 48 Rimonabant 48 Darvon 48 Fortigel 48 Febuxostat 48 capsule formulation 48 Pfizer Geodon 47 Rosiglitazone 47 decongestants expectorants antihistamines 47 nasal calcitonin product 47 Colazal 47 OSCS 47 OMRI 47 Generic Versions 47 Qualaquin 47 Seroquel XR 47 Complete Response Letter 47 OIRA 47 Aplenzin 47 Menaflex 47 Torisel 47 sNDAs 47 Cangrelor 47 Dulera 47 generic Copaxone 47 Allergan 47 Entocort 47 Palatin Technologies 47 Plenaxis TM 47 Afinitor everolimus 47 BLA submission 47 Omapro 47 Preos 47 KV Pharma 47 gave Makena orphan 47 buccal tablets 47 ezogabine 47 Serious Side Effects 47 ZEGERID Capsules 47 insulin inhaler 47 Zarnestra 47 moxidectin 47 rivaroxaban Xarelto 47 casopitant 47 Wyeth Progenics 47 Expedited Review 47 Centralized Procedure 47 Trobalt 47 HPV vaccine GlaxoSmithKline Cervarix 47 QNEXA 47 NitroMist TM 47 generation defibrillator Protecta 47 MAP Pharma 47 Rasilez HCT 47 Weight Loss Drug 47 Norian XR 47 ARIXTRA R 47 PROTONIX 47 ixabepilone 47 gelcaps 47 Fosphenytoin 47 teratogenicity 47 Retacrit 47 Pfizers 47 COLAZAL 47 Patanase 47 supplemental Biologics License Application 47 GlucaGen 47 Vpriv 47 infant formula contaminant 47 Tekturna HCT 47 NZFSA 47 Supplemental Biologics License Application 47 GRALISE 47 tainted heparin 47 MK #B 47 Zolpimist 47 Augment Bone Graft 47 successfully commercialize Silenor 47 Cerepro 47 Alogliptin 47 Cylert 47 MelaFind 47 ARCOXIA 47 Vitrasert R 47 fluvoxamine maleate 47 Xanodyne Pharmaceuticals 47 NEBIDO 47 Natrecor 47 Evista 47 Abstral 47 OROS R Hydromorphone 47 Ixempra 47 ANVISA 47 Onrigin 47 Pfizer Sutent 47 eCTD format 47 Durolane 47 cloned livestock 47 Cerezyme Fabrazyme Myozyme Aldurazyme 47 CDSCO 47 Rapaflo 47 clopidogrel bisulfate 47 Frova ® 47 Fampyra 47 Xience 47 temporarily wheezing shortness 47 Prescription Drug User Fee 47 sulfated chondroitin sulfate 47 Upsher Smith 47 aripiprazole Abilify 47 ulipristal 47 GRAS notification 47 Advair Diskus 47 Endeavor Drug Eluting 47 revoke Menaflex approval 47 Zelapar 47 Elestrin TM 47 Cintredekin besudotox 47 contaminated heparin 47 milligram dosage 47 imminent Phusion Projects 47 enoxaparin sodium 47 Junovan 47 Vandetanib 47 Firazyr 47 Manufacturing Practices GMPs 47 Pirfenidone 47 Digoxin 47 Teflaro 47 DORIBAX 47 Ropinirole 47 Cellular Tissue 47 Velaglucerase Alfa 47 Ethex 47 Homeopathic Pharmacopoeia 47 Galvus vildagliptin 47 Augment ™ Bone Graft 47 Regulatory Agency MHRA 47 Ampligen 47 Reimportation 47 Premarket Approval Application 47 Intrinsa 47 Yan Jiangying spokeswoman 47 rosiglitazone Avandia 47 Lipofen 47 fexofenadine 47 Provenge 47 Contrave NDA 47 pharmacovigilance 47 FDA Medwatch 47 heterozygous FH 47 Pfizer Celebrex 47 American Bullie AB 47 Medicinal Products EMEA 47 Linjeta ™ 47 Celgene Revlimid 47 conjugated estrogen 47 VelaSmooth 47 Steris 47 FDA Pulmonary Allergy 47 Tasigna nilotinib 47 Sporanox 47 Factive 47 Encysive Pharmaceuticals 47 VIAject 47 Heparin Sodium 47 Matrixx Initiatives 47 Wellstat 47 Michael Beckerich 47 Humira adalimumab 47 Certican 47 Bioequivalence 47 Kweder 47 Pfizer Bextra 47 Premarket Approval PMA 47 Feraheme ® 47 Food Additive 47 Encysive 47 Glaxo Serevent 47 TachoSil 47 Oncology Drug 47 Sapien valve 47 MedImmune Vaccines Inc. 47 Stelara 47 Viracept 47 Priority Review 47 Aegerion 47 Humenza 47 Generic Version 47 PREVU x 47 Zavesca 47 Zimulti 47 Livalo 47 DPP4 inhibitor 47 FluLaval 47 Cardizem CD 47 #mg #mg #mg #mg [002] 47 Esbriet 47 Keppra ® levetiracetam 47 Ozurdex 47 Inhaled insulin 47 JANUMET 47 ACUROX ® 47 renal toxicity 47 Gamunex C 47 Rofecoxib 47 dissolvable tobacco 47 Scolr 47 Tekturna HCT ® 47 Folotyn 47 guanfacine extended release 47 Arzerra 47 CORTOSS Bone Augmentation Material 47 Arena Pharmaceuticals ARNA 47 Drugs BFAD 47 Sycrest 47 MoviPrep 47 Rhucin ® 47 generic Allegra 47 Kapidex 47 Baytril 47 AneuRx 47 cervical cancer vaccine Cervarix 47 Biosimilars 47 faropenem 47 Levemir 47 Drug Controller 47 Psychopharmacologic Drugs Advisory 47 Cypher stents 47 Anchen 47 carotid stent 47 nitrofurantoin 47 BiDil XR 47 NOXAFIL 47 containing sibutramine 47 Generally Regarded 47 Iressa gefitinib 47 Vitaros 47 Aloxi Injection 47 Purepac 47 Synthon 47 Corlux 47 sNDA 47 drugmakers 47 Paxil paroxetine 47 levetiracetam Keppra 47 CODEX 46 Tykerb 46 Crestor 46 ISMP 46 placebo controlled studies 46 MEVACOR 46 BLA resubmission 46 Humalog insulin 46 Moxatag 46 PRISTIQ 46 Mofcom 46 Douglas Petkus 46 Priligy 46 TNF blocker 46 Ampyra 46 DYSPORT 46 collagen meniscus implant 46 Gynazole 1 46 Xyrem ® 46 diabetes pill Avandia 46 nonprescription 46 NJDHSS 46 EVICEL 46 TPSAC 46 FENTORA 46 Rilutek 46 Xience V stent 46 Coreg CR 46 bioequivalence 46 compounding pharmacists 46 ENLIGHT 46 Barr Laboratories Inc. 46 PROVIGIL 46 Xolair 46 Cleviprex 46 Medicinal Products 46 Prezista 46 easypod R 46 Solstice Neurosciences 46 anti arrhythmic 46 mesylate tablets 46 Foradil Aerolizer 46 Synerx 46 Anidulafungin 46 Wellbutrin bupropion 46 Adverse Event Reporting 46 Vibativ 46 Ticagrelor 46 Dr. Rafel Rieves 46 Biogen 46 Heart Stents 46 Arthritis Drugs 46 bovine thrombin 46 Complete Prescribing Information 46 FDA MedWatch 46 Vioxx Successor 46 inhalable 46 Biogen Elan 46 Pentacel vaccine 46 Viapro 46 Bayer Xarelto 46 ICH guidelines 46 Product Characteristics 46 Dacogen injection 46 Inhaled Insulin 46 EMBEDA 46 Pradaxa 46 Kristalose ® prescription 46 Consumerlab.com 46 pharmaceutical 46 Xiaflex 46 Eli Lilly Cymbalta 46 Prescribing Information 46 Telzir 46 Baxter Heparin 46 EMBEDA ™ 46 SFDA approval 46 Meloxicam Tablets 46 Topiramate tablets 46 prGCD 46 Evamist 46 indiplon capsules 46 Zelrix 46 Latuda 46 Soriatane 46 Augment ™ 46 Acthar Gel 46 non selective NSAIDs 46 Darvocet Darvon 46 Vidaza azacitidine 46 Pfizer Lyrica 46 Viibryd 46 anticlotting drug 46 Xibrom QD 46 Fast Track designations 46 Baxter heparin 46 biogenerics 46 ConsumerLab 46 poultry medication Baytril 46 Somatuline R Autogel R 46 Mepact 46 blood thinner Heparin 46 Qlaira 46 EGRIFTA TM