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(Click for frequent words.) 54 eMDR 53 Arthritis Drug 53 Anemia Drug 52 Inhaled Insulin 52 Stronger Warnings 52 PREVU x 51 Approvable 51 Prescribers 51 Schizophrenia Drug 50 Weight Loss Drug 50 Bayer Onyx 50 Arthritis Drugs 50 biologics FOBs 50 Heartburn Drugs 50 Cholesterol Drug 50 Contaminated Heparin 50 #k Clearance 49 Heart Stents 49 devicemakers 49 Amgen Nplate 49 Blood Pressure Drug 49 Wyeth Progenics 49 Eli Lilly Zyprexa 49 eSubmissions 49 FDAs 49 Implantable Defibrillators 49 Lung Cancer Drug 49 FDA 49 FDAAA 49 Generic Versions 48 PREVU x LT 48 Biogen Elan 48 Drug Approvals 48 Drug Makers 48 Biogenerics 48 PDUFA Date 48 Glaxo Avandia 48 ImClone Erbitux 48 generic biologic 48 postmarket surveillance 48 Generic Lovenox 48 GSK Avandia 48 Drugmakers 48 pharma cos 48 Accelerated Approval 48 Cardiac Defibrillators 48 Pfizer inhaled insulin 48 Lilly Cymbalta 48 cGMPs 48 ICH guidelines 48 postmarket studies 47 UCB Keppra 47 F.D.A. 47 Generic Protonix 47 Anzemet 47 Expanded Indication 47 Devices Advisory Panel 47 Device Makers 47 Expedited Review 47 Bayer Xarelto 47 Unapproved Drugs 47 Mitigation Strategies REMS 46 Ensure Compliance 46 Improper Payments 46 ARIXTRA R 46 Drug Fails 46 Stricter Rules 46 Novartis AG Foradil 46 Postmarket 46 Premarket Approval 46 premarket notification 46 Authorized Generic 46 AstraZeneca Brilinta 46 Biosimilar 46 OTC Mevacor 46 Biosimilars 46 postapproval 45 Augment ™ 45 Postmarketing 45 Zyprexa Cymbalta 45 Bioequivalence 45 darbepoetin alfa Aranesp 45 overthe counter 45 Amgen Prolia 45 Genzyme Myozyme 45 User Fee Act 45 postmarket safety 45 Generic Version 45 QbD 45 midodrine 45 COX 2s 45 Combating Counterfeit Drugs 45 biogeneric 45 OTC ZEGERID 45 Prostate Cancer Vaccine 45 Biogen Idec Elan 45 Pandemic Vaccine 45 Clinical Trials Directive 45 Counterfeit Drugs 45 SANVAR 45 AstraZeneca Iressa 45 Warning Label 44 Generic Drug 44 Bayer Trasylol 44 Salix Pharma 44 Payors 44 Merck Rotateq 44 Pfizer Exubera 44 Pfizer Sutent 44 Vytorin Zetia 44 PGx 44 Tighter Controls 44 Interagency Guidance 44 Elan Tysabri 44 Generic Version Of 44 Medtronic stent 44 Genetically Modified Salmon 44 OraTest 44 Prescribing Information 44 Generic Zocor 44 FDA Advisory Panel 44 Sanofi Acomplia 44 Noxafil 44 propoxyphene containing 44 Bifeprunox 44 FOSAMAX PLUS D 44 Morphine Sulfate 44 PDUFA reauthorization 44 Voraxaze 44 FDA Modernization Act 44 Pharmas 44 KV Pharma 44 Merck Januvia 44 Regranex 44 PMPRB 44 Whistleblower Protection 44 Merck Schering 43 Tanezumab 43 maker Barr Pharmaceuticals 43 Asmanex 43 FOIA Requests 43 FDA Accepts 43 Nonprescription 43 Drug Maker 43 Boxed Warning 43 DNAwithPap TM Test 43 Glaxo Cervarix 43 Breach Notification 43 Sanctura XR 43 FDA Accelerated Approval 43 Acthar Gel 43 GlaxoSmithKline Plc Avandia 43 biogeneric drugs 43 AneuRx 43 Roche Xeloda 43 Xifaxan 43 Biotechs 43 Roche Avastin 43 Botox Botox Cosmetic 43 AstraZeneca Symbicort 43 Orphan Status 43 Levothyroxine Sodium 43 Anti Infectives 43 GlucaGen 43 CDRH 43 Ramelteon 43 Amgen Vectibix 43 PhosLo 43 Implantable Cardioverter Defibrillators 43 Flutiform ™ 43 Elan Biogen 43 rhThrombin 43 Serious Side Effects 43 Exelbine NDA 42 Cellegesic 42 BioDelivery Sciences 42 Baxter Heparin 42 Kynapid 42 Big Pharmas 42 balsalazide tablet 42 Adverse Event Reporting 42 GSK Cervarix 42 authority Gurian Sherman 42 XM Sirius Merger 42 Doc Fix 42 TOPROL XL 42 Trobalt 42 Amgen Aranesp 42 Shelhigh 42 biosimilars 42 Lipofen 42 Long Term Viability 42 Ticagrelor 42 UCB Cimzia 42 Credit Raters 42 Dendreon Provenge 42 Lax Oversight 42 MDUFMA 42 Comparative Effectiveness 42 AVANDIA 42 AM Vitals 42 Cladribine 42 Metozolv ODT 42 Pfizer Zyvox 42 drugmakers 42 orphan medicinal 42 Receives Tentative FDA 42 injectable formulations 42 antibiotic Ketek 42 PDUFA Prescription Drug 42 Orapred ODT 42 Symbyax 42 BioDelivery 42 Zelnorm Zelmac 42 FDICIA 42 Genzyme Isis 42 Referenced EEG 42 Reimportation 42 Sanofi Lovenox 42 HCl capsules 42 Ozurdex 41 BIG PHARMA 41 Misleading Advertising 41 comparative effectiveness 41 Vivus Qnexa 41 Product Roadmap 41 varenicline tartrate 41 biosimilar medicines 41 Fda 41 Vibativ 41 Supplemental Biologics License Application 41 Kiacta 41 Darvon Darvocet 41 Dutasteride 41 Zometa zoledronic acid 41 Manual Processes 41 MyVax 41 Cintredekin besudotox 41 regulatory 41 Telzir 41 OvaDx 41 REMS 41 Endeavor Drug Eluting 41 Electronic Submission 41 Azathioprine 41 Pixuvri 41 Complete Response 41 Foradil Aerolizer 41 LibiGel ® 41 FDA Adverse Event 41 Encysive Pharmaceuticals Nasdaq ENCY 41 Revised Guidelines 41 Montelukast 41 OSI Pharma 41 Standards CFATS 41 Marketing Authorisation Application 41 EXALGO 41 Abbott Humira 41 Biologic License Application 41 Marketing Authorization Applications 41 PharmaVitae Profile 41 FDA Approves Generic 41 OLEPTRO 41 Subpart H 41 Genentech Provides Update 41 ERGEG 41 Sanofi Aventis Acomplia 41 Sustained Growth 41 Sycrest 41 Ustekinumab 41 Product Characteristics 41 Visicol 41 Biogen Tysabri 41 Serious Flaws 41 Anti Dumping Duties 41 BRILINTA 41 WTC Rebuilding 41 Merck Vioxx 41 cholesterol reducers 41 allergen labeling 41 Surfaxin lucinactant 41 RIGScan CR 41 Allergan Botox 41 elavil 41 Associations EFPIA 41 Biegelsen 40 Dostinex 40 Biogen IDEC 40 Nabi HB Intravenous 40 REACH RoHS 40 Zensana 40 Zyflo 40 Amevive 40 WHO prequalification 40 NeutroSpec 40 Civacir 40 Regulatory 40 Lorqess 40 Counter Cholesterol 40 Vimpat R 40 Hylenex 40 Celebrex celecoxib 40 OsmoPrep 40 postmarketing surveillance 40 Unpaid Overtime 40 biogenerics 40 bioresearch monitoring 40 Menaflex implant 40 Praecis 40 Gralise 40 METOZOLV ODT 40 Merck Gardasil 40 Comcast NBCU Merger 40 Receives Approvable Letter 40 Drug Administration Amendments 40 Antitrust Laws 40 Act FDAAA 40 segment Biotest 40 Avastin bevacizumab 40 RoHS WEEE 40 Indiplon 40 Celgene Revlimid 40 pulls Darvon painkiller 40 Metabolic Drugs 40 Issues Resolved 40 Muraglitazar 40 Pfizer Geodon 40 Subpart E 40 generic Allegra 40 Emend 40 metoprolol succinate 40 ONSOLIS 40 anticlotting drug 40 Avandia rosiglitazone 40 Bazedoxifene 40 ENLIGHT 40 Reduce Operational 40 Generic Plavix 40 Cubicin 40 topical NSAID 40 Pirfenidone 40 Potiga 40 Vioxx Successor 40 Supply Constraints 40 Anti Terrorism Measures 40 Spiriva HandiHaler 40 Icatibant 40 Toprol 40 Frova R 40 Antitrust Regulators 40 Glycopyrrolate 40 Paragraph IV 40 Cites Flaws 40 FDA Approval 40 Vertex hepatitis C 40 PDE inhibitors 40 AdreView 40 Lilly Zyprexa 40 Hatch Waxman Amendments 40 devicemaker 40 Viviant 40 Big Pharma 40 Taxus Liberte 40 Too Costly 40 Arranon 39 Patent expiries 39 Diastat 39 GPhA 39 Pfizer Lyrica 39 Placebo Effect 39 Consumer Preferences 39 Cardizem CD 39 Arxxant 39 Zyflo CR 39 generic Copaxone 39 postmarketing 39 Mepact 39 Structural Changes 39 Complaint Handling 39 NDA BLA 39 INTUNIV TM 39 FDA Psychopharmacologic Drugs 39 Pulmonary Allergy Drugs 39 Xifaxan rifaximin 39 Eli Lilly Cymbalta 39 Refiling 39 FDA Antiviral Drugs 39 sNDAs 39 Marketing Authorization Application 39 Therapeutic Monoclonal Antibodies 39 Qualaquin 39 Stock Option Expensing 39 drug eluting coronary stents 39 Effient 39 Certican 39 Genentech Avastin 39 Trade Pacts 39 Ixempra 39 FCC Net Neutrality 39 Goozner 39 Entereg 39 Relistor 39 Biosante 39 evista 39 alvimopan 39 Anti infectives 39 Tequin 39 Novartis Prexige 39 FDA Circulatory System 39 Genzyme Sanofi 39 temporarily wheezing shortness 39 LensAR Laser System 39 eCTD format 39 Debate Intensifies 39 XenoPort XNPT 39 Thyrogen 39 Zavesca 39 Novartis Galvus 39 fda 39 Galvus 39 Recommends Changes 39 Abbott ABT 39 Cindy Skrzycki 39 Genetic Therapies Directorate 39 Intelence 39 postmarketing studies 39 Exelon PSEG 39 Zenpep 39 Trends Influencing 39 Orexigen Contrave 39 Citizen Petition 39 Hexvix 39 Zicam Cold Remedy Swabs 39 eCTD submission 39 Passenger Screening 39 Genentech Roche 39 Fosrenol 39 Optison 39 PROVIGIL 39 celebrex celecoxib 39 @ FierceBiotech 39 Focalin XR 39 Humalog insulin 39 Atryn 39 Doribax 39 Pfizers 39 MDCO 39 Amyvid 39 Bureaucracies 39 Cethromycin 39 Arena Pharmaceuticals ARNA 39 FDAâ € ™ 39 Drug Administration www.fda.gov 39 Glaxo Advair 39 HIPAA HITECH 39 eCTD submissions 39 Kombiglyze XR 39 FENTORA 39 Pre IND 39 Enteryx 39 Emezine 39 Drug Adminstration 38 casopitant 38 Egrifta 38 Zegerid OTC 38 generic biologics 38 Amylin Byetta 38 CCH INSURANCE SERVICES 38 Evicel 38 OHRP 38 Seriously Flawed 38 EMBEDA 38 Safeguards Rule 38 Bristol Myers Squibb Abilify 38 Drug Administration 38 ANVISA 38 Velac 38 NDA resubmission 38 Impede 38 Febuxostat 38 Deficit Cutting 38 BiDil XR 38 Tougher Stance 38 faropenem 38 India DCGI 38 Premarket Approval Application 38 pharmacoeconomic 38 indiplon capsules 38 Approves Sweeping 38 BioShield 38 Pharmaceutical 38 Rasilez HCT 38 Glatiramer Acetate 38 Natroba 38 Sarbannes Oxley 38 MEPACT 38 multiple dose vials 38 regulators 38 molecular entities NMEs 38 Cancidas 38 PFIZER 38 FDA Approvable Letter 38 Generic Pharmaceutical 38 iDMS 38 Purepac 38 Firms 38 ICH E# 38 Alnara Pharmaceuticals 38 Gets Subpoena 38 Merck Schering Plough 38 MHLW 38 Tekturna HCT 38 insulin inhaler 38 Gitmo Panels 38 Heparin Sodium 38 Vigamox 38 FDA reviewers 38 Merck Arcoxia 38 Regulatory Developments 38 MEMO/#/# [002] 38 Inhaled insulin 38 ZEGERID Chewable Tablets 38 Invirase 38 Advair Diskus 38 Ranexa 38 Biologics Licensing 38 Xarelto 38 Zemplar 38 postmarket 38 Commoditization 38 Neupro 38 requiring Asthmatx 38 Oncology Drug 38 LDTs 38 cethromycin NDA 38 Glucosamine Chondroitin 38 PMA Supplement 38 Inefficiencies 38 Notified Bodies 38 Tredaptive 38 Ms. Katen 38 antinausea 38 Optimark 38 Velaglucerase Alfa 38 approvable letters 38 DYSPORT 38 Restore Confidence 38 NMEs 38 generic Lovenox 38 Break Deadlock 38 NerPharMa 38 moxidectin 38 Device Manufacturers 38 fosamax 38 Reassure Investors 38 equivalent Reglan 38 Harsh Interrogation 38 @ FiercePharma 38 successfully commercialize Silenor 38 Encysive 38 ICH GCP 38 Aloxi Injection 38 JANUMET 38 Fortical R 38 Marketing Authorization 38 Aptivus 38 CigRx TM 38 procyclical effects 38 Onsolis 38 Myfortic 38 MAP Pharma 38 FACTIVE R gemifloxacin 38 Probing Possible 38 Amgen Enbrel 38 PROTONIX 38 Regulatory Frameworks 38 orphan designation 38 Emissions Standards 38 Tamsulosin 38 Biologic 38 CERVARIX R 38 Tighten Border 38 Elio Evangelista senior 38 Mitigation Strategy REMS 38 blockbuster Plavix 38 Dificid 38 PRISTIQ 38 Xience 38 Linjeta 38 carotid stent 38 Deepening Recession 37 Adequately Capitalized 37 Vcall Interactive 37 Chemicals REACH 37 Firazyr 37 GEM #S ® 37 Sarbox 37 Hedge Funds Private Equity 37 painkiller Prexige 37 Dr. Pazdur 37 BioGlue ® 37 Exec Pay 37 SEASONALE 37 Dermacyn Wound Care 37 Carries Risks 37 Lobbying Disclosure 37 Generic drugmakers 37 AstraZenca 37 Harsh Interrogations 37 PMA submission 37 Consumerlab.com 37 Drug Administration Modernization Act 37 biosimilar versions 37 regrow hair 37 AstraZeneca Crestor 37 Formal Probe 37 Generics 37 Court Overrules 37 blood thinner prasugrel 37 Zarnestra 37 Alimta pemetrexed 37 Pharma cos 37 Frova ® 37 Boiler MACT 37 Systemically Important 37 SURFAXIN 37 T Pred 37 Keppra ® levetiracetam 37 MMSEA 37 GRC Governance Risk 37 Rosiglitazone Evaluated 37 Receives Subpoena 37 Coreg CR 37 Vioxx Celebrex 37 Regulators 37 Panel Suggests 37 Underscores Need 37 NOXAFIL 37 Worker Productivity 37 AstraZeneca Nexium 37 Panel Faults 37 Applications ANDA 37 DORIBAX 37 Rimonabant 37 eCTD 37 Nano Scale 37 ANDA applicant 37 Reexamine 37 Merck RotaTeq 37 Tylenol Cold 37 Generic 37 Transkaryotic 37 HIPAA Privacy Rule 37 NOPR 37 NitroMist TM 37 Options Backdating 37 biopharmas 37 Greatly Improved 37 Competent Authorities 37 revoke Menaflex approval 37 Novartis Diovan 37 MAA submission 37 Sporanox 37 Analytical Method 37 Lipitor atorvastatin 37 Exalgo 37 Complete Prescribing Information 37 Dexilant 37 Soriatane 37 Bioshield 37 GlaxoSmithKline Plc Novartis AG 37 Worksite Enforcement 37 OROS R Hydromorphone 37 Mylan Labs 37 Complies With 37 Retacrit 37 Panel Examines 37 FluLaval 37 PREVU x POC 37 Tyvaso 37 Chipmakers 37 GRALISE 37 k Premarket Notification 37 FDA Complete Response 37 Interrogation Tactics 37 Document Retention 37 Zelapar 37 Policies Procedures 37 Clin Trials 37 ANDA filings 37 Steep Rise 37 Zeneus 37 PDUFA 37 @ JohnCFierce 37 Uloric 37 Drug Administration FDA 37 AstraZeneca MedImmune 37 DCGI 37 FASB IASB 37 cheaper generics 37 gadobutrol 37 SOX Sarbanes Oxley 37 artemisinin monotherapy 37 atrasentan 37 Pathogen Reduction 37 Drug Resistant Tuberculosis 37 Therapeutics Bulletin DTB 37 Adcirca 37 Immune Therapy 37 decongestants expectorants antihistamines 37 exenatide Byetta 37 Exanta 37 heterozygous FH 37 Metformin GR 37 Increase Efficiencies 37 Ofirmev 37 ZEGERID Capsules 37 Xinlay 37 Velcade bortezomib 37 Sanofi Genzyme 37 Valeant Pharma 37 ABT.N Quote Profile Research 37 Cellcept 37 Dacogen injection 37 liver resection surgeries 37 American Bullie AB 37 Tasigna nilotinib 37 ALK inhibitors 37 Colazal 37 nasal calcitonin product 37 Certriad 37 Horizant 37 Manufacturers 36 Afinitor everolimus 36 Tape Backup 36 Acomplia Rimonabant 36 Mofcom 36 Arzerra 36 Byetta 36 FALCPA 36 CORTOSS Bone Augmentation Material 36 Factive 36 clopidogrel bisulfate 36 Revised Upward 36 Rapaflo 36 Conflicting Interests 36 generic gabapentin 36 TapImmune 36 hoFH 36 practices GMPs 36 excessively burdensome 36 Muken 36 overregulate 36 K Dur 36 Antitrust Ruling 36 Fusilev 36 Centralized Procedure 36 Airline Delays 36 Viagra Levitra 36 Endo Pharma 36 Pharma Biotech 36 Cesamet 36 Humenza 36 Could Backfire 36 Cleviprex 36 Deadline Arrives 36 Bristol Myers BMY 36 pharmas 36 Registration Evaluation Authorization 36 Teva TEVA 36 patent expirations 36 Solvency II directive 36 Acomplia rimonabant 36 Tort Reform 36 Organizational Structure 36 Elestrin TM 36 Cost Estimating 36 NitroMist 36 wrinkle smoothing Botox 36 GLP GMP 36 Performance Appraisal 36 Plenaxis TM 36 Spiriva Handihaler 36 successfully commercialize Iluvien 36 HepaGam B 36 NRAs 36 FDIC Bair 36 Proposes Tougher 36 Merck Suspends Lobbying 36 biologic medicines 36 HSCRC 36 Paladin Labs 36 mg canada 36 Auxilium Pharma 36 Stelara 36 ATryn 36 Anidulafungin 36 Rotarix ® 36 Rx Dx 36 DDMAC 36 bloodthinner 36 Amifostine 36 Bioaccelerate compounds under 36 CBS4 Investigates 36 biomarker validation 36 Partneringreview 36 Political Upheaval 36 Forest Laboratories FRX 36 USDA FSIS 36 Allergan 36 Amgen anemia 36 Plenaxis R 36 CFTC Gensler 36 injectable gel 36 guanfacine extended release 36 miconazole MBT 36 Emission Controls 36 cytotoxics 36 Cypress Bioscience 36 Faces Mounting 36 Pfizer Wyeth 36 Pentacel vaccine 36 Propoxyphene 36 SPARLON 36 Injectafer 36 Pierre Fabre SA 36 Vimovo 36 unapproved narcotic painkillers 36 Durolane 36 Lilly Evista 36 levothyroxine sodium 36 Colleague infusion pump 36 APF# NDA 36 Hycamtin 36 Risperidone Oral Solution 36 Decentralize 36 antidepressant Serzone 36 Folotyn 36 Drugmaker 36 Cerezyme Fabrazyme Myozyme Aldurazyme 36 painkillers Celebrex 36 Harmonization 36 CureDM 36 GxP 36 Video Surveillance Cameras 36 END FOOTNOTE 36 pill Avandia 36 Nuedexta 36 CDER 36 Sapien valve 36 Security Breaches 36 ustekinumab 36 Genentech Herceptin 36 Communications DDMAC 36 Accolate 36 Pfizer Selzentry 36 OVATION Pharmaceuticals 36 Corlux 36 GMPs 36 Liprotamase 36 CorVel Announces 36 Female Viagra 36 Organizations ACRO 36 MEVACOR 36 Trevor Mundel 36 Solvency II Directive 36 daily Glumetza TM 36 Zicam Cold Remedy Gel 36 Personalised medicine 36 Expert Discusses 36 Steris 36 med tech 36 Chertoff Defends 36 OraTest R 36 IFRS changeover 36 REACH Regulation 36 MethyPatch 36 Patent Trolls 36 Xyotax 36 Menaflex device 36 Cyberattack 36 Mevacor OTC 36 Therapeutic Goods Administration TGA 36 Drug Administration Oncologic Drugs 36 Vitaros 36 prGCD 36 Multibillion Dollar 36 Viagra Cialis Accutane 35 QNEXA 35 Regulatory Structure 35 COLAZAL 35 Genzyme Corp 35 Key Accountabilities 35 AIR inhaled insulin 35 Xarelto rivaroxaban 35 Humira adalimumab 35 statins Zocor 35 Drug Submission 35 Formal Request 35 Facial Recognition Software 35 Schering Plough NYSE SGP 35 Poses Risks 35 inhalable insulin 35 Increlex 35 AFSSAPS 35 Spending Intentions 35 compliancy requirements 35 prescribe Zyprexa 35 Anti Counterfeit 35 Ceftobiprole 35 Authorizations 35 Automakers 35 Settle Antitrust 35 Xolair 35 Recothrom 35 Wellstat 35 Metformin Hydrochloride 35 infant formula contaminant 35 Cites Lack 35 Genetic Manipulation 35 Tablet Device 35 Drug Administration FDA Endocrinologic 35 ARCOXIA 35 Human Genome lupus 35 MFN clauses 35 biologics 35 Procrit 35 Broadened 35 Item 9A 35 Poses Risk 35 Device Manufacturer 35 Shuren 35 teratogenicity 35 antibiotic Cubicin 35 accounting rulemakers 35 EGRIFTA TM 35 AdvaMed 35 Avastin 35 immune reconstitution syndrome 35 Kaletra tablet 35 TWYNSTA ® 35 jurisdictional thresholds 35 Foodmakers 35 Draw Scrutiny 35 bio similars 35 EMBEDA ™ 35 collagen meniscus implant 35 Torisel 35 Avastin Herceptin 35 motavizumab 35 Cephalon 35 antipsychotic Seroquel 35 blood thinner Lovenox 35 Probe Update1 35 Synerx 35 Digoxin 35 Rosiglitazone 35 Razadyne 35 Drug 35 Teva Copaxone 35 Darvocet Darvon 35 Somatuline R Autogel R 35 Armour Thyroid 35 Troxatyl TM 35 Broadest Range 35 Prioritized 35 Kapidex 35 Process Reengineering 35 Micro electromechanical 35 Zelrix 35 eczema creams 35 Natrecor 35 Encysive Pharmaceuticals 35 aripiprazole Abilify 35 Fablyn 35 Olmesartan 35 Publicly Funded 35 Removab 35 RotaShield 35 AIFM Directive 35 Sanofi Aventis Ambien 35 auditor attestation 35 ICH Q8 35 Chiron CHIR 35 Launches Probe Into 35 anidulafungin 35 Vitrasert R 35 Goldcredit International Enterprises 35 Stavzor 35 Zyprexa schizophrenia 35 antipsychotic Risperdal 35 Reevaluation 35 UnitedHealth PacifiCare 35 Amgen 35 PT Indofarma 35 Generic Medicines 35 Manufacturing Practices GMPs 35 BLA filing 35 biosimilar