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Biotech/Pharma - Regulatory
Novartis AG (NVS), Roche (RHHBY) Cry Foul On New Swiss Pricing System 9/16/2014
Alchem International Commits To Tropane Alkaloid Apis And Extends Production And Regulatory Support To Resolve Supply Gap 9/15/2014
FDA's Surprise Visit To Sun Pharmaceutical Industries Ltd (SUNPHARMA.NS)'s Pressures Stock 9/12/2014
Rock Creek Pharmaceuticals Receives New Dietary Ingredient Notification (NDIN) Response 9/12/2014
Tianyin Pharmaceutical Co, Inc. Release: JCM Applies For Azithromycin API Import Certificate At India 9/9/2014
Columbia Laboratories, Inc. (CBRX) Announces Completion Of CRINONE License Renewal 9/8/2014
Cleveland Biolabs Inc. (CBLI) Announces Green Light To Submit Pre-Emergency Use Authorization Application For Entolimod 9/4/2014
Ex-Researcher From Now-Dissolved Cetero Rebukes FDA Over Warning Letter 9/4/2014
Ganeden Biotech Release: USP Issues Testing Standards Monograph For GanedenBC30. 9/3/2014
Cleveland Biolabs Inc. (CBLI) To Report Outcome Of July FDA Meeting And Host Conference Call On September 3 9/3/2014
Ajinomoto Althea, Inc. Receives European GMP Certification 9/3/2014
U.S. FDA Grants QIDP Status For Wockhardt (WOCKHARDT.BO) Anti-Infective Drug Discovery Program 9/2/2014
Tianyin Pharmaceutical Co, Inc. Submits Dataset For GMP Inspection At Qionglai Facility (QLF) 8/29/2014
FDA Chastises Alexion Pharmaceuticals Inc. (ALXN) For Production Problems Again 8/28/2014
m2p-labs' Environmental Management System Successfully Certified 8/27/2014
Cesca Therapeutics Advocates Benefits Of Cell Therapy To The Centers for Medicare & Medicaid Services 8/27/2014
CEN Biotech Announces The Completion Of Its Pre-License Inspection By Health Canada 8/26/2014
Apotex Inc. Release: NAFTA Tribunal Decision Supports FDA And Its Actions 8/26/2014
SANAFOR™ Antimicrobial Technology For Plastics, From Janssen PMP, Receives U.S. EPA Registration 8/21/2014
Exco Intouch Achieves Quality Milestone With Iso9001:2008 Certification 8/21/2014
FDA Finds Falsified Data, Serious Mold, And Decaying Frogs At Amanta (Formerly Known As Marck Biosciences) 8/21/2014
WuXi PharmaTech Co., Ltd. Facility Passes FDA Inspection For Manufacture Of API 8/18/2014
CVS Caremark Corporation (CVS)'s Accordant Health Services Receives NCQA Disease Management Accreditation 8/18/2014
Tianyin Pharmaceutical Co, Inc. Release: Qionglai Facility (QLF) Schedules September For GMP Examination 8/18/2014
FDA Advisory Committee Recommends Approval Of Tiotropium Respimat® For The Maintenance Treatment Of COPD 8/15/2014
Brunswick Labs Certification Program 2014 Q2 Activity Report 8/14/2014
Popular Toothpaste Contains Cancer-Causing Ingredient 8/13/2014
Protein Sciences Corporation And Liomont Announce Licensing Of Proprietary Influenza Vaccines For The Mexico Market 8/12/2014
Easton Pharmaceuticals (OP: EAPH) Announces Medical Marijuana Site Facility Visit And Inspection 8/12/2014
ZAI Lab Of Shanghai In-Licenses Two Respiratory Drugs From Sanofi 8/12/2014
Androgen Study Group Urges Investigation Into Ethical Violations By JAMA Regarding Controversial Testosterone Study 8/11/2014
Advanced Cell Diagnostics, Inc. Receives ISO 13485:2003 Certification 8/11/2014
Cardiome Pharma Corp. (COM.TO) Submits BRINAVESS Dossier To French Authorities To Support Market Access 8/7/2014
MD Anderson Cancer Center Postdoc Faked Results Of Novartis AG (NVS) Brain Tumor Study 8/7/2014
FDA Will Regulate Thousands Of Cancer, Genetic, And Other Diagnostic 8/5/2014
Raptor Pharmaceutical Inc. (RPTP) Receives Orphan Drug Designation For Cysteamine Bitartrate In Huntington's Disease From The European Commission 8/4/2014
ibidi Awarded With Seal Of Quality 8/4/2014
ATS Labs Release: EPA Approves Protocols For Antimicrobial Fogging & Misting Application Claims 8/4/2014
IMPAX Laboratories, Inc. (IPXL)'s Hayward Facility Continues To Disappoint The FDA 8/4/2014
Rock Creek Pharmaceuticals Provides Update Of Its European Drug Development Regulatory Strategy And Selects Quotient Clinical For Its Early Development Programs 8/1/2014
FDA Concern Over Drug Production Process At India's Cadila 7/31/2014
Israel's Ministry Of Health Approves Pluristem Therapeutics (PSTI)'s Commercial-Scale 3D Cell Manufacturing Process Used At Its New Haifa Facility 7/31/2014
Successful FDA Inspection At Hovione's API Manufacturing Plant In Cork, Ireland 7/31/2014
IMPAX Laboratories, Inc. (IPXL) Parkinson's Drug Future Shaky As FDA Cites Factory Issues 7/30/2014
Ampio Pharmaceuticals, Inc. (AMPE) Announces The FDA Has Issued A Written Response And Accepted The Ampio Plan For Beginning Production Of Ampion™ In The New Facility 7/30/2014
FDA Performs Inspection Of IMPAX Laboratories, Inc. (IPXL)'s Taiwan Facility 7/29/2014
Parnell Pharmaceuticals Holdings Acquires License For Intellectual Property And Rights To Develop Compounds For Bone And Dermal Regeneration 7/25/2014
Do Drugmakers Use An FDA Safety Program To Thwart Generics? 7/24/2014
India's Ipca Laboratories Halts Shipments To U.S. From Local Plant After FDA Concerns 7/24/2014
Agenus (AGEN) Release: First Vaccine Candidate for Malaria is Accepted for EU Regulatory Review 7/24/2014
Access Pharmaceuticals (ACCP) Receives 510(K) FDA Marketing Clearance For ProctiGard™ 7/22/2014
Vivione Biosciences Receives AOAC Certification, Positions Brand For Fast Growth In Food Industry 7/22/2014
Unique Pharmaceuticals, Ltd. Announces A Voluntary Nationwide Recall Of All Sterile Compounded Preparations Within Their Expiry Period Due To A Lack Of Sterility Assurance 7/21/2014
AltheaDx Laboratory Receives Accreditation From College of American Pathologists 7/21/2014
Novartis AG (NVS) Plant To Fall Under GlaxoSmithKline (GSK) Control 7/18/2014
Seres Health Makes Push For First Drug, And IPO, Of Microbiome Era 7/17/2014
Zynex (ZYXI.OB) Achieves Compound Pharmacy License Approval In 36 States 7/17/2014
U.S. Officials Fire 11 Scientists On Biosafety Panel In Midst Of Anthrax Crisis 7/16/2014
Repros Therapeutics Inc. (RPRX) Release: FDA Confirms Sperm And Testosterone Endpoints As Key Parameters For Assessment Of Androxal® Versus Approved Topical Gel And Placebo 7/16/2014
Federal Trade Commission Urged To Probe Shire, Sanofi (France) (SAN.PA) & Icahn Med School Over A "Conspiracy" 7/16/2014
AntiOp Release: FDA Designates Opioid Overdose Treatment For Fast Track Development Program 7/15/2014
Roche (RHHBY)'s Avastin Wins Priority Review For Cervical Cancer 7/15/2014
Bial And moksha8 Announce Exclusive License For The Commercialization Of Eslicarbazepine Acetate (Zebinix® / Exalief®) In Brazil And Mexico 7/15/2014
Ariad Pharmaceuticals, Inc. (ARIA) Announces Continuation Of Iclusig Review Under The Article 20 Procedure In Europe 7/14/2014
Questcor Pharmaceuticals, Inc. (QCOR) Finally Fesses Up To Adverse Events Data For Acthar 7/14/2014
QRxPharma Ltd. (QRXPY) Provides Feedback On End-of-Review Meeting With The FDA On Moxduo® 7/11/2014
HbA1c-direct™ From Carolina Liquid Chemistries Receives NGSP Certification 7/9/2014
GlaxoSmithKline (GSK) Has 30 Days To Clean Up Plant 7/8/2014
Aesica Meets New Serialization Requirements With A QAD ERP Upgrade 7/8/2014
Protein Sciences Corporation Receives Approval From FDA For 2014/15 Formulation Of Flublok® Influenza Vaccine 7/8/2014
Teva Pharmaceutical Industries Limited (TEVA) Tries Out A New Tactic In Battle For Generic MS Drug 7/7/2014
Beximco Pharmaceuticals Becomes First Bangladeshi Company To Receive GMP Approval From Taiwan Food and Drug Administration (TFDA) 7/7/2014
Recordati S.p.A : Carbaglu® Receives Orphan Drug Designation In The U.S. For Organic Acidemias 7/3/2014
Advaxis, Inc. Announces Filing For USDA Product License 7/2/2014
Aratana Therapeutics (PETX) Files For USDA Product License Of AT-014 Canine Osteosarcoma Immunotherapy 7/2/2014
FDA Slaps GlaxoSmithKline (GSK) With Warning For Plant Quality Violations, Orders Company To Review Manufacturing Worldwide 6/26/2014
Provista Diagnostics Laboratory Receives Accreditation From College of American Pathologists 6/26/2014
European Medicines Agency Release: Outcome Report On First European Collaboration Between Regulators And HTA Organisations 6/25/2014
Burzynski Research Institute Announces Lifting Of The FDA Partial Clinical Hold - Phase 3 Clinical Study Agreed Upon 6/24/2014
Cellectis (ALCLS)’ UCART19 Receives Advanced-Therapy Medicinal Product Classification From European Medicines Agency 6/23/2014
Centene Corporation's Kansas Subsidiary Awarded Accreditation From NCQA 6/18/2014
GrowBLOX Sciences, Inc. Secures Special Use Permit For Its Cultivation And Conversion Facility 6/18/2014
Harrisvaccines Becomes First In The Nation To Receive United States Department Of Agriculture (USDA) Conditional License For PEDv Vaccine 6/17/2014
US FDA Advisory Committee Recommends No Cardiovascular Outcomes Trial For Peripherally-Acting Mu-Opioid Receptor Antagonist (Pamora) Class Including Movantik 6/13/2014
AstraZeneca PLC (AZN) Release: FDA Adcom Recommends No CV Trial For PAMORA Class 6/13/2014
TxCell Granted Certificate Of GMP Compliance From ANSM For Cell Therapy Manufacturing Facility 6/12/2014
Sirion Biotech Release: Adenovirus Vectors Meet Critical FDA Requirement Regarding Risk Of Contamination With Infectious Agents 6/12/2014
European Medicines Agency Agrees Policy On Publication Of Clinical Trial Data With More User-Friendly Amendments 6/12/2014
Catalyst Clinical Resourcing, LLC Certified As A Woman Business Enterprise 6/10/2014
EffRx Receives U.S. Orphan Drug Designation For EX404 For Treatment Of Pediatric Polycystic Ovary Syndrome 6/10/2014
Europeans, U.S. Disagree Over Safety Of Ranbaxy Laboratories (RANBAXY.BO) Facility 6/6/2014
National Organization for Rare Disorders Urges FDA To Consider Rare Disease Treatment Implications When Setting Biologics Naming Policy 6/4/2014
PCI Given The Green Light In Anvisa Audit 6/4/2014
Sirona Biochem Announces Wanbang Biopharmaceuticals's Launch Of Pre-Clinical Validation 6/3/2014
IHMML Receives Conditional Zoning Approval From The Corporation Of Delta 6/2/2014
FDA Cites Manufacturing Concerns At Wockhardt (WOCKHARDT.BO)'s U.S. Unit 5/28/2014
Eisai Company, Ltd. (ESALY.PK)'s R&D Subsidiary Kan Research Institute Commences Full-Scale Operation at New Facility 5/26/2014
RXi Pharmaceuticals (RXII) Granted U.S. Notice Of Allowance Covering Self-Delivering (Sd-Rxrna) Technology Platform 5/22/2014
TxCell Release: Col-Treg Granted Advanced Therapy Medicinal Product (ATMP) Classification By The European Medicines Agency 5/22/2014
FDA Slams Sun Pharmaceutical Industries Ltd (SUNPHARMA.NS) For Continued Violations At Plant 5/22/2014
WuXi PharmaTech Co., Ltd. Toxicology Facility In Suzhou Passes OECD GLP Inspection 5/21/2014
CoreRx Expands Clinical Trial Supplies Manufacturing And Packaging 5/20/2014
Nordic Nanovector: Betalutin™ Granted Orphan-Drug Designation In The USA 5/20/2014
Medac Pharma, Inc. Announces Successful FDA Inspection Of Its Exclusive Methotrexate Manufacturer 5/15/2014
WuXi PharmaTech Co., Ltd. Facilities For Late- And Commercial-Stage Analytical And Stability Testing And Clinical-Trial Materials Manufacturing Pass FDA Audit 4/30/2014
Flamel Technologies (FLML) Announces Receipt Of Complete Response Letter From FDA Citing Issues At The Facility Of The Supplier Of The Active Ingredient 4/29/2014
Anaheim Clinical Trials (ACT) Clears Another FDA Inspection 4/29/2014
Pluristem Therapeutics (PSTI)'s Manufacturing Facility Approved By European Auditors For Phase 3 Trials 4/28/2014
Plandai Biotechnology, Inc. (PLPL.OB) Petitions South Africa Department Of Health For License To Conduct Cannabis Research 4/28/2014
Tolero Pharmaceuticals Receives FDA Orphan Drug Designation For Alvocidib For The Treatment Of Acute Myeloid Leukemia 4/23/2014
Salix Pharmaceuticals, Ltd. (SLXP) And Progenics Pharmaceuticals, Inc. (PGNX) Announce The Acceptance Of Submission To Expand The Use Of RELISTOR In Chronic Non-Cancer Pain By European Medicines Agency 4/22/2014
Vivione Biosciences Receives Coveted Letter Of No Objection (LNO) Designation From U.S. Department Of Agriculture Food Safety & Inspection Services 4/22/2014
Coldstream Laboratories Inc. Completes Successful FDA Inspection 4/21/2014
Lonza Inc.'s Facility In Singapore Received Good Manufacturing Practice (GMP) Certification From The HSA 4/17/2014
High Tech Solution For Controlling The Dengue Mosquito Is Approved By CTNBio 4/11/2014
FDA Release: Avita Medical Grants An Investigational Device Exemption For Compassionate Use Of ReCell 4/10/2014
ECCRT, A SynteractHCR Company, Recognized As An Accredited Training Facility By TransCelerate BioPharma 4/8/2014
FDA Moving Slow To Add Drug Inspectors In China 4/8/2014
Nexcyon Achieves European Regulatory Decision 4/7/2014
ChemCon GmbH Successfully Passes Its Fourth FDA Inspection 4/3/2014
Clinovo Release: Hands-On Trainings To Convert Clinical Data To CDISC SDTM Standards With CDISC Express 4/1/2014
IntegenX Announces ISO 9001:2008 Certification 4/1/2014
Abaxis, Inc. (ABAX) Receives CLIA Waiver For Capillary Sampling For Cholesterol, HDL And Triglycerides 4/1/2014
FDA Staff Raises Questions About MannKind Corporation (MNKD) Diabetes Device 3/28/2014
AXIS Clinicals Announces Successful Completion Of 13th U.S. FDA Audit 3/27/2014
Claimspartner® Becomes Second CIS Service Based Offering To Attain SSAE 16 Compliance 3/20/2014
Aesica Successfully Completes The Validation Of Its High Capacity Manufacturing Facility At Queenborough, UK Site 3/14/2014
POLARIS Announces Illumina CSPro Certification For Sequencing 3/14/2014
Northwest Biotherapeutics (NWBO) Receives Authorization For New Cancer Therapy In Accordance With $4 Billion German Medical Act 3/12/2014
ISPE To Conduct Quality Metrics Pilot Program With FDA Participation 3/12/2014
Mettler-Toledo (MTD) Release: Shedding New Light On Compliance And Regulatory Challenges 3/7/2014
FDA Approves Pluristem Therapeutics (PSTI)'s Commercial Scale Cell Manufacturing Process 3/6/2014
Regulatory Affairs Professionals Society Release: 257 Earn Regulatory Affairs Certification in Autumn 2013 3/5/2014
Pharmaron LLC Earns CFDA GLP Certification For Toxicology Facility 3/4/2014
Basilea Pharmaceutica (BSLN.SW) Reports That Isavuconazole Receives Qualified Infectious Disease Product Designation From FDA For The Treatment Of Invasive Mucormycosis 2/27/2014
ChinaBio(R) LLC Release: China Implements 30-Day Review For "Simple" M&A Transactions 2/26/2014
BioNJ Targets Streamlined Therapeutic Development With Clinical Trials Master Service Agreement Template 2/25/2014
Neurosearch A/S (NEUR.CO) Announces The Danish Business Authority's Decision In The Accounting Control Matter 2/21/2014
SCYNEXIS, Inc. Receives Qualified Infectious Disease Product (QIDP) Designation From The FDA For Antifungal Agent SCY-078 For Oral Use 2/21/2014
Intertek Microbiology Laboratory Achieves Bio-Safety Level 2 2/21/2014
Pluristem Therapeutics (PSTI) Submits FDA Orphan Drug Application For Preeclampsia 2/20/2014
Guerbet (GBT) Receives FDA Approval For A New Manufacturing Plant For Lipiodol® (Ethiodized Oil) Injection 2/20/2014
Selvita Received A GMP Certificate 2/18/2014
Shire plc's Massachusetts Facility Wins FDA OK To Manufacture Gaucher Disease Drug 2/14/2014
Pfizer Inc. (PFE) Statement On Today’s Joint Meeting Of FDA Advisory Committees 2/12/2014
TNI BioTech Announces SEC Clearance Of Form 10 Registration Statement And Clears Way To Upgrade To A Higher Exchange 2/12/2014
GMP Certification Boost For Cobra Biologics Ltd. 2/11/2014
Rho Offers Insight On Key Components Of New Drug Application Submissions 2/6/2014
BIOCOM Applauds Passage Of Farm Bill 2/5/2014
NextPharma Completes Successful U.S. FDA Inspection With No Observations 2/3/2014
Regulatory Affairs Professionals Society Updates The Essential Reference On Canadian Regulatory Affairs 1/30/2014
Ranbaxy Laboratories (RANBAXY.BO) Workers Fudged Test Results: FDA 1/28/2014
Victrex Obtains ISO Certification For Environmental Management System 1/28/2014
Aratana Therapeutics (PETX) Announces Conditional Approval Of Second Canine-Specific Antibody Therapy 1/28/2014
Corden Pharma Colorado Receives Potent Compound Safety Certification Approval From SafeBridge Consultants, Inc.® 1/27/2014
NextSource Biotechnology Announces FDA Short Supply Release Of The Formally Known Bristol-Myers Squibb Company (BMY) (CeeNu®) Brand Oncology Product Now Currently Marketed Under the NextSource Biotechnology Lomustine (CCNU) Exclusively In The U.S. 1/27/2014
Protalix Biotherapeutics, Inc. (PLX) Announces Successful Manufacturing Facility Evaluation By Health Canada 1/24/2014
Cantrell Drug Company Updates FDA Registration to 503B Outsourcing Facility 1/24/2014
Pluristem Therapeutics (PSTI)'s Cell Manufacturing Facility Marks Major Milestone With German Regulatory Approval Of New Scaled-Up 3D Manufacturing Process 1/23/2014
Suven Life Sciences Ltd's Pashamylaram's Unit Receives FDA Acceptance 1/22/2014
Regis Technologies, Inc. Reports Successful FDA Audit With No Form 483 Observations 1/21/2014
Fraunhofer IZI Granted Manufacturing Authorization For Second GMP Facility 1/21/2014
Exco InTouch Successfully Completes HIPAA Security Audit 1/20/2014
Bayer HealthCare (BAY) Commends AHS And CAPC For Updated Heartworm Guidelines 1/20/2014
ChinaBio(R) LLC Release: China Adds Regs To New IPO Process 1/17/2014
Vectura Group plc (VEC.L): Swedish Regulatory Authority Confirm Approval Of Airflusal® Forspiro® 1/14/2014
Evidera Announces Release FDA Draft Guidance On Use Of The "EXACT" To Measure Symptoms Of COPD Exacerbations 1/14/2014
Smithers Pira Lansing Laboratory Achieves Key Accreditation For Medical Device And Pharmaceutical Product Testing 1/14/2014
Innovus Pharma Provides Regulatory And Commercial Update On The Label Indication For Zestra® For Female Sexual Desire Disorder ("FSDD") From Health Canada 1/10/2014
Cardeas Pharma Announces That FDA Grants QIDP Designation And Fast Track Review For The Company's Antibiotic Combination Product 1/8/2014
BASF Received Excipact™ Certification As Pharmaceutical Excipient Supplier 1/8/2014
Hospira, Inc. (HSP) In Hot Water As FDA Formally Slaps Indian Plant With Warning 12/27/2013
Two ISPE Studies Cited In FDA Statement to Congress 12/23/2013
TaiGen Biotechnology Receives Qualified Infectious Disease Product And Fast Track Designations From The FDA For Nemonoxacin (Taigexyn®) 12/23/2013
Daiichi Sankyo, Inc. (4568.t) To Help Ranbaxy Laboratories (RANBAXY.BO) Meet FDA Norms 12/19/2013
Caris Life Sciences Receives Tumor Profiling Industry's First ISO 15189 Medical Laboratory Accreditation 12/19/2013
Provectus Pharmaceuticals Inc. Type C Meeting With FDA Oncology Division Held December 16, 2013 12/18/2013
Cambrex Corporation (CBM) Manufacturing Facility Completes Successful FDA Inspection 12/17/2013
Cellceutix (CTIX) Submits Application For IRB Review To Commence Phase 2b Clinical Trial Of Novel Antibiotic Brilacidin 12/16/2013
INSYS Therapeutics Receives Subpoena From Office Of Inspector General 12/13/2013
Valent BioSciences Corporation Earns ISO 9001:2008 Re-certification Following A System-Wide Audit 12/12/2013
R-Biopharm Rhône Ltd Welcomes Scottish Government Moves To Improve Food Safety Standards 12/12/2013
NovaBay Pharmaceuticals, Inc. (NBY) Gains ISO 13485 Certification For The Design And Manufacturing Of Neutrophase® 12/11/2013
Easton Pharmaceuticals (OP: EAPH) Provides Update On Initiatives Towards Its Cancer Drug 12/11/2013
Biogen Idec, Inc. (Massachusetts) (BIIB) Plant That Makes Older MS Drugs Fails An FDA Inspection 12/10/2013
Reckitt Benckiser Pharmaceuticals Inc. Pharma Unit In The U.S. Is Raided By The Feds 12/9/2013
Frontage Laboratories Receives Approval For Manufacture Of Schedule I And Schedule II Drug Products 12/9/2013
China Agrees To Allow Ten Additional FDA Inspectors 12/9/2013
ARCA biopharma Announces IDE Submission To FDA For Gencaro Companion Diagnostic Test 12/5/2013
Wockhardt (WOCKHARDT.BO) Falls 4%, FDA Says Company Erased Key Trial Data 12/4/2013
FDA Approval For SCM Pharma Limited Following BTG plc (BTG.L)'s Drug Approval 12/3/2013
TxCell Obtains Manufacturing Accreditation Status For Its French Cell Therapy Manufacturing Facility 12/3/2013
ChemCon GmbH Receives Approval To Manufacture Semi-Solid Pharmaceuticals For Human Use 12/3/2013
Eisai Company, Ltd. (ESALY.PK) Submits Application For Proton Pump Inhibitor Pariet In Japan 11/28/2013
Unique Pharmaceuticals Applauds Passage Of Drug Quality And Security Act 11/27/2013
FDA Schedules Face To Face Meeting With Repros Therapeutics Inc. (RPRX) To Discuss Androxal® Efficacy 11/25/2013
Biogen Idec, Inc. (Massachusetts) (BIIB) Release: CHMP Determines Dimethyl Fumarate In TECFIDERA® To Be A New Active Substance In The European Union 11/22/2013
Cytori Therapeutics, Inc. (CYTX) Comments On New Legislation For Regenerative Medicine In Japan 11/21/2013
Gentium S.p.A. Receives European Medicines Agency Orphan Drug Designation For Defibrotide For The Prevention Of GvHD 11/19/2013
Amgen (AMGN) and Sanofi (France) (SAN.PA) Drugs Can Reach U.S. Without Long Studies 11/15/2013