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Biotech/Pharma - Regulatory
Lonza Inc.'s Facility In Singapore Received Good Manufacturing Practice (GMP) Certification From The HSA 4/17/2014  More...
High Tech Solution For Controlling The Dengue Mosquito Is Approved By CTNBio 4/11/2014  More...
FDA Release: Avita Medical Grants An Investigational Device Exemption For Compassionate Use Of ReCell 4/10/2014  More...
ECCRT, A SynteractHCR Company, Recognized As An Accredited Training Facility By TransCelerate BioPharma 4/8/2014  More...
FDA Moving Slow To Add Drug Inspectors In China 4/8/2014  More...
Nexcyon Achieves European Regulatory Decision 4/7/2014  More...
ChemCon GmbH Successfully Passes Its Fourth FDA Inspection 4/3/2014  More...
Clinovo Release: Hands-On Trainings To Convert Clinical Data To CDISC SDTM Standards With CDISC Express 4/1/2014  More...
IntegenX Announces ISO 9001:2008 Certification 4/1/2014  More...
Abaxis, Inc. (ABAX) Receives CLIA Waiver For Capillary Sampling For Cholesterol, HDL And Triglycerides 4/1/2014  More...
FDA Staff Raises Questions About MannKind Corporation (MNKD) Diabetes Device 3/28/2014  More...
AXIS Clinicals Announces Successful Completion Of 13th U.S. FDA Audit 3/27/2014  More...
Claimspartner® Becomes Second CIS Service Based Offering To Attain SSAE 16 Compliance 3/20/2014  More...
Aesica Successfully Completes The Validation Of Its High Capacity Manufacturing Facility At Queenborough, UK Site 3/14/2014  More...
POLARIS Announces Illumina CSPro Certification For Sequencing 3/14/2014  More...
Northwest Biotherapeutics (NWBO) Receives Authorization For New Cancer Therapy In Accordance With $4 Billion German Medical Act 3/12/2014  More...
ISPE To Conduct Quality Metrics Pilot Program With FDA Participation 3/12/2014  More...
Mettler-Toledo (MTD) Release: Shedding New Light On Compliance And Regulatory Challenges 3/7/2014  More...
FDA Approves Pluristem Therapeutics (PSTI)'s Commercial Scale Cell Manufacturing Process 3/6/2014  More...
Regulatory Affairs Professionals Society Release: 257 Earn Regulatory Affairs Certification in Autumn 2013 3/5/2014  More...
Pharmaron LLC Earns CFDA GLP Certification For Toxicology Facility 3/4/2014  More...
Basilea Pharmaceutica (BSLN.SW) Reports That Isavuconazole Receives Qualified Infectious Disease Product Designation From FDA For The Treatment Of Invasive Mucormycosis 2/27/2014  More...
ChinaBio(R) LLC Release: China Implements 30-Day Review For "Simple" M&A Transactions 2/26/2014  More...
BioNJ Targets Streamlined Therapeutic Development With Clinical Trials Master Service Agreement Template 2/25/2014  More...
Neurosearch A/S (NEUR.CO) Announces The Danish Business Authority's Decision In The Accounting Control Matter 2/21/2014  More...
SCYNEXIS, Inc. Receives Qualified Infectious Disease Product (QIDP) Designation From The FDA For Antifungal Agent SCY-078 For Oral Use 2/21/2014  More...
Intertek Microbiology Laboratory Achieves Bio-Safety Level 2 2/21/2014  More...
Pluristem Therapeutics (PSTI) Submits FDA Orphan Drug Application For Preeclampsia 2/20/2014  More...
Guerbet (GBT) Receives FDA Approval For A New Manufacturing Plant For Lipiodol® (Ethiodized Oil) Injection 2/20/2014  More...
Selvita Received A GMP Certificate 2/18/2014  More...
Shire plc's Massachusetts Facility Wins FDA OK To Manufacture Gaucher Disease Drug 2/14/2014  More...
Pfizer Inc. (PFE) Statement On Today’s Joint Meeting Of FDA Advisory Committees 2/12/2014  More...
TNI BioTech Announces SEC Clearance Of Form 10 Registration Statement And Clears Way To Upgrade To A Higher Exchange 2/12/2014  More...
GMP Certification Boost For Cobra Biologics Ltd. 2/11/2014  More...
Rho Offers Insight On Key Components Of New Drug Application Submissions 2/6/2014  More...
BIOCOM Applauds Passage Of Farm Bill 2/5/2014  More...
NextPharma Completes Successful U.S. FDA Inspection With No Observations 2/3/2014  More...
Regulatory Affairs Professionals Society Updates The Essential Reference On Canadian Regulatory Affairs 1/30/2014  More...
Ranbaxy Laboratories (RANBAXY.BO) Workers Fudged Test Results: FDA 1/28/2014  More...
Victrex Obtains ISO Certification For Environmental Management System 1/28/2014  More...
Aratana Therapeutics (PETX) Announces Conditional Approval Of Second Canine-Specific Antibody Therapy 1/28/2014  More...
Corden Pharma Colorado Receives Potent Compound Safety Certification Approval From SafeBridge Consultants, Inc.® 1/27/2014  More...
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  More...
Protalix Biotherapeutics, Inc. (PLX) Announces Successful Manufacturing Facility Evaluation By Health Canada 1/24/2014  More...
Cantrell Drug Company Updates FDA Registration to 503B Outsourcing Facility 1/24/2014  More...
Pluristem Therapeutics (PSTI)'s Cell Manufacturing Facility Marks Major Milestone With German Regulatory Approval Of New Scaled-Up 3D Manufacturing Process 1/23/2014  More...
Suven Life Sciences Ltd's Pashamylaram's Unit Receives FDA Acceptance 1/22/2014  More...
Regis Technologies, Inc. Reports Successful FDA Audit With No Form 483 Observations 1/21/2014  More...
Fraunhofer IZI Granted Manufacturing Authorization For Second GMP Facility 1/21/2014  More...
Exco InTouch Successfully Completes HIPAA Security Audit 1/20/2014  More...
Bayer HealthCare (BAY) Commends AHS And CAPC For Updated Heartworm Guidelines 1/20/2014  More...
ChinaBio(R) LLC Release: China Adds Regs To New IPO Process 1/17/2014  More...
Vectura Group plc (VEC.L): Swedish Regulatory Authority Confirm Approval Of Airflusal® Forspiro® 1/14/2014  More...
Evidera Announces Release FDA Draft Guidance On Use Of The "EXACT" To Measure Symptoms Of COPD Exacerbations 1/14/2014  More...
Smithers Pira Lansing Laboratory Achieves Key Accreditation For Medical Device And Pharmaceutical Product Testing 1/14/2014  More...
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  More...
Cardeas Pharma Announces That FDA Grants QIDP Designation And Fast Track Review For The Company's Antibiotic Combination Product 1/8/2014  More...
BASF Received Excipact™ Certification As Pharmaceutical Excipient Supplier 1/8/2014  More...
Hospira, Inc. (HSP) In Hot Water As FDA Formally Slaps Indian Plant With Warning 12/27/2013  More...
Two ISPE Studies Cited In FDA Statement to Congress 12/23/2013  More...
TaiGen Biotechnology Receives Qualified Infectious Disease Product And Fast Track Designations From The FDA For Nemonoxacin (Taigexyn®) 12/23/2013  More...
Daiichi Sankyo, Inc. (4568.t) To Help Ranbaxy Laboratories (RANBAXY.BO) Meet FDA Norms 12/19/2013  More...
Caris Life Sciences Receives Tumor Profiling Industry's First ISO 15189 Medical Laboratory Accreditation 12/19/2013  More...
Provectus Pharmaceuticals Inc. Type C Meeting With FDA Oncology Division Held December 16, 2013 12/18/2013  More...
Cambrex Corporation (CBM) Manufacturing Facility Completes Successful FDA Inspection 12/17/2013  More...
Cellceutix (CTIX) Submits Application For IRB Review To Commence Phase 2b Clinical Trial Of Novel Antibiotic Brilacidin 12/16/2013  More...
INSYS Therapeutics Receives Subpoena From Office Of Inspector General 12/13/2013  More...
Valent BioSciences Corporation Earns ISO 9001:2008 Re-certification Following A System-Wide Audit 12/12/2013  More...
R-Biopharm Rhône Ltd Welcomes Scottish Government Moves To Improve Food Safety Standards 12/12/2013  More...
NovaBay Pharmaceuticals, Inc. (NBY) Gains ISO 13485 Certification For The Design And Manufacturing Of Neutrophase® 12/11/2013  More...
Easton Pharmaceuticals (OP: EAPH) Provides Update On Initiatives Towards Its Cancer Drug 12/11/2013  More...
Biogen Idec, Inc. (Massachusetts) (BIIB) Plant That Makes Older MS Drugs Fails An FDA Inspection 12/10/2013  More...
Reckitt Benckiser Pharmaceuticals Inc. Pharma Unit In The U.S. Is Raided By The Feds 12/9/2013  More...
Frontage Laboratories Receives Approval For Manufacture Of Schedule I And Schedule II Drug Products 12/9/2013  More...
China Agrees To Allow Ten Additional FDA Inspectors 12/9/2013  More...
ARCA biopharma Announces IDE Submission To FDA For Gencaro Companion Diagnostic Test 12/5/2013  More...
Wockhardt (WOCKHARDT.BO) Falls 4%, FDA Says Company Erased Key Trial Data 12/4/2013  More...
FDA Approval For SCM Pharma Limited Following BTG plc (BTG.L)'s Drug Approval 12/3/2013  More...
TxCell Obtains Manufacturing Accreditation Status For Its French Cell Therapy Manufacturing Facility 12/3/2013  More...
ChemCon GmbH Receives Approval To Manufacture Semi-Solid Pharmaceuticals For Human Use 12/3/2013  More...
Eisai Company, Ltd. (ESALY.PK) Submits Application For Proton Pump Inhibitor Pariet In Japan 11/28/2013  More...
Unique Pharmaceuticals Applauds Passage Of Drug Quality And Security Act 11/27/2013  More...
FDA Schedules Face To Face Meeting With Repros Therapeutics Inc. (RPRX) To Discuss Androxal® Efficacy 11/25/2013  More...
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  More...
Cytori Therapeutics, Inc. (CYTX) Comments On New Legislation For Regenerative Medicine In Japan 11/21/2013  More...
Gentium S.p.A. Receives European Medicines Agency Orphan Drug Designation For Defibrotide For The Prevention Of GvHD 11/19/2013  More...
Amgen (AMGN) and Sanofi (France) (SAN.PA) Drugs Can Reach U.S. Without Long Studies 11/15/2013  More...
Investors Can Sleep Soundly As FDA Panel Backs Vanda Pharmaceuticals, Inc. (VNDA)'s Drug For The Blind 11/15/2013  More...
Mylan Inc. (MYL) Applauds New Federal Legislation To Increase Anaphylaxis Preparedness In Schools 11/14/2013  More...
Remediation To Continue Through 2014 At Hospira, Inc. (HSP)'s Rocky Mount 11/11/2013  More...
Drug Regulator Asks Sun Pharmaceutical Industries Ltd to Halt Clinical Research at Mumbai Laboratory 11/11/2013  More...
NanoViricides, Inc. (NNVC.PK) Announces that DengueCide™ Has Received Orphan Drug Designation From the European Medicines Agency 11/11/2013  More...
Specialised Therapeutics Australia Receives Therapeutic Goods Administration Approval for Brain Tumour Visualisation Drug - Gliolan® 11/11/2013  More...
FDA Slaps Aegerion Pharmaceuticals, Inc. (AEGR) CEO For "Serious" Violations Of Drug Promotion Law Following CNBC Interview 11/11/2013  More...
Put Down That Doughnut: FDA Takes on Trans Fats 11/8/2013  More...
Pharmagen Announces FDA Registration 11/6/2013  More...
Cynosure, Inc. (CYNO) Receives Australian Regulatory Approval to Market PicoSure™, the First Picosecond Laser to Remove Tattoos and Benign Pigmented Lesions 11/6/2013  More...
ACGT, Inc. Accredited by the Clinical Laboratory Improvement Amendments (CLIA) Program 11/5/2013  More...
ISPE Named as a Source in FDA Strategic Plan for Preventing and Mitigating Drug Shortages 11/1/2013  More...
Bio-Matrix Scientific Group Inc. (BMSN.OB)' Regen BioPharma Retains Cook General Biotechnology for Contract Manufacturing of HemaXellerate I 10/31/2013  More...
Eisai Company, Ltd. (ESALY.PK) Submits Application To Expand Indication Of Anti-Alzheimer's Agent Aricept® As Treatment For Dementia With Lewy Bodies In Japan 10/31/2013  More...
Specialty Pharmaceutical Formulation Developer Integral Biosystems, LLC Gets USPTO Trademark Approval for Integral's OcuSurf™ Product 10/28/2013  More...
Mesoblast Limited (MSB.AX) Updates Market on Registration Plans for GVHD Cell Product in Japan 10/28/2013  More...
Bridging Studies – What You Need to Know 10/24/2013  More...
Cambridge Major Laboratories Europe, B.V. Announces Successful Cambridge Major Laboratories, Inc. Inspection at Weert Facility 10/22/2013  More...
UK Regulator to Withdraw Approval for Wockhardt (WPL)'s Daman Plant 10/22/2013  More...
Novasep's European Custom Manufacturing Passes FDA Inspection 10/22/2013  More...
Cambridge Major Laboratories, Inc. Announces Successful FDA Inspection At Weert Facility 10/21/2013  More...
Eppendorf AG Announces It Has Received Connecticut State Approval to Conduct Biosafety Level 2 Infectious Disease Related Research 10/21/2013  More...
WuXi PharmaTech Co., Ltd. Receives CLIA Certification for Its Genomics Clinical Laboratory 10/17/2013  More...
CMC Biologics Achieves Authorization for cGMP Commercial Manufacturing by the Danish Medicines Agency 10/15/2013  More...
Wockhardt (WPL) Falls After U.K. Regulator Action on Factory 10/14/2013  More...
Biotechnology Industry Organization (BIO) Disappointed Governor Brown Vetoed Patient Access to Biosimilars Bill 10/14/2013  More...
Comprehensive Portfolio Prepared by The Alliance for Regenerative Medicine (ARM) Guides Companies Through Reimbursement Process 10/14/2013  More...
Ranbaxy Laboratories (RANBAXY.BO) Jumps as US Plant Wins FDA Clearance 10/11/2013  More...
Fujifilm Diosynth Biotechnologies' UK Site Receives Renewed Medicines and Healthcare Products Regulatory Agency Manufacturing Licence 10/9/2013  More...
Easton Pharmaceuticals (OP: EAPH) Announces Application to Obtain a Distributorship License Towards Its Canadian Medical Marijuana Initiatives 10/4/2013  More...
The Jackson Laboratory Genomic Medicine Obtains State of Connecticut Clinical Laboratory Licensure and CLIA Certificate of Registration 10/2/2013  More...
Grassley Probes Two Drugmakers Over 340B Pricing Program 9/27/2013  More...
DermTech International Initiates Commercial Testing and Validation of Assay in New Laboratory Facilities 9/25/2013  More...
Oxygen Biotherapeutics, Inc. (OXBO) Submits to FDA Results of Requested Nonclinical Studies 9/23/2013  More...
Achaogen Announces Agreement With FDA on a Special Protocol Assessment for a Phase 3 Clinical Trial of Plazomicin to Treat Infections Caused by Carbapenem-Resistant Enterobacteriaceae (CRE) 9/23/2013  More...
FDA Accuses USV of Fudging Data 9/23/2013  More...
ImmunoGen, Inc. (IMGN) Announces Positive Regulatory Decisions for Roche (RHHBY)'s Kadcyla® in the European Union and Japan 9/20/2013  More...
VIVUS, Inc. (VVUS) Updates European Filing Strategy for Qsiva 9/20/2013  More...
AntiOp, Inc. Release: Naloxone Nasal Spray on Development Fast Track as Emergency Treatment for Opioid Overdose 9/20/2013  More...
PCI Synthesis Announces Successful FDA Inspection and Pre-Approval of Two Products 9/19/2013  More...
Failure by Drugmakers, Researchers to Publish Clinical Trial Results Risk Patient Safety: UK Lawmakers 9/17/2013  More...
Medivir AB (MVIRb.F): The Regulatory Process in Japan for Simeprevir 9/17/2013  More...
Forest Laboratories, Inc. (FRX)'s Ceftazidime/avibactam Combination Receives Qualified Infectious Disease Product (QIDP) Designation From FDA 9/13/2013  More...
GlycoMimetics, Inc. Announces European Medicines Agency’s Granting of Orphan Drug Status in European Union for GMI-1070 in Sickle Cell Disease 9/13/2013  More...
BioIndustry Association Flagship UK Bioscience Forum is Now CPD-Certified 9/12/2013  More...
RayBiotech Awarded ISO 13485 Certification 9/12/2013  More...
NicOx SA (COX.PA) Receives Positive Opinion for European Orphan Drug Designation for Naproxcinod for the Treatment of Duchenne Muscular Dystrophy 9/11/2013  More...
Aegerion Pharmaceuticals, Inc. (AEGR)' Lomitapide Receives Orphan Drug Designation in Japan for the Treatment of Homozygous Familial Hypercholesterolemia 9/9/2013  More...
TG Therapeutics, Inc. (MHA)' Ublituximab (TG-1101) Receives Orphan Drug Designation for the Treatment of Nodal Marginal Zone Lymphoma and Extranodal Marginal Zone Lymphoma (Mucosa-Associated Lymphatic Tissue, MALT) 9/9/2013  More...
CEL-SCI (CVM)'s Manufacturing and Laboratory Operations Deemed Compliant With GMP Requirements Following Audit by European Union Qualified Person for a Second Time 9/9/2013  More...
New Regulatory Affairs Professionals Society Book Covers FDA Regulation of Drug Promotions, Including Social Media 9/5/2013  More...
European Medicines Agency Now Accepts SAFE-BioPharma, LLC Digital Signatures on eSubmissions 9/5/2013  More...
UK's National Institute for Clinical Excellence (NICE) Final Appraisal Determination (FAD) Confirms Positive Recommendation for ThromboGenics NV (TBGNF)' JETREA® for Treatment of Vitreomacular Traction and Macular Hole 9/3/2013  More...
Procognia Limited Announces Receipt of cGMP Certificate for Its Glycosylation Analysis Services 9/3/2013  More...
Regulatory Affairs Professionals Society Allows Free Access to Regulatory Focus Throughout September 9/3/2013  More...
Lonza Inc. Issues Guidance on Infection Control Regarding Novel Coronaviruses (nCoV), Including the Middle East Respiratory Syndrome Coronavirus (MERS-CoV) 8/29/2013  More...
BioPharm Executive: Not All States are Biosimilar 8/28/2013  More...
Navidea Biopharmaceuticals (NAVB) Announces Centers for Medicare & Medicaid Services Issuance of Lymphoseek® Reimbursement Pass-Through C Code, Effective as of October 1, 2013 8/21/2013  More...
CareMed Pharmaceutical Services Earns URAC Accreditation 8/21/2013  More...
Johnson & Johnson (JNJ): We Achieved a "Major Milestone" at Our Troubled OTC Plant 8/20/2013  More...
European Union Grants a Good Manufacturing Practice Certificate to Nelson Laboratories 8/20/2013  More...
Federal Trade Commission Submits Proposed Amicus Brief Concerning "No-Authorized-Generic" Commitments in Drug Companies' Patent Settlements 8/20/2013  More...
Nutra Pharma Corp. (NPHC) Provides Update on US Military and US Government Registrations 8/19/2013  More...
BakerHostetler Continues to Build FDA Practice With Attorney Hire in Washington, D.C. 8/19/2013  More...
Tianyin Pharmaceutical Co, Inc. Facility Received GMP Renewal by CFDA 8/16/2013  More...
AIBioTech Release: Fairfax Identity Laboratories Earns American Association of Blood Banks Re-Accreditation 8/16/2013  More...
Nuvo Research Inc. (NRI.TO) Announces Mallinckrodt Inc. Submits PK Study Report in Response to PENNSAID® 2% FDA Complete Response Letter 8/15/2013  More...
Innovastics, LLC Licensed Exclusive Rights to Commercialize OEA (Oleoylethanolamide) for Healthy Appetite, Body Fat Management 8/14/2013  More...
Centralized Statistical Monitoring Techniques From CluePoints Cited in New FDA Guidance for Improved Data Quality 8/12/2013  More...
Acorda Therapeutics (ACOR) Has a Hard Time Following Instructions: FDA 8/12/2013  More...
FDA Grants Orphan Drug Status to Eisai Inc. (ESALF.PK)'s Investigational Compound (E7777) for Cutaneous T-Cell Lymphoma 8/8/2013  More...
Lyophilization Services of New England Successfully Completes MHRA Inspection 8/7/2013  More...
GH Genhelix Receives GMP Approval 8/6/2013  More...
FDA Approves BioGaia's Request for Orphan Drug Designation 8/6/2013  More...
Regulatory Affairs Professionals Society Release: 223 Earn Regulatory Affairs Certification 8/6/2013  More...
After Novartis AG (NVS) Scandal, Japan Considers Penalties for False Data 8/6/2013  More...
Biologix Hair Inc. Voluntarily Suspends SEC Reporting Obligations 8/5/2013  More...
Itonis Pharmaceuticals, Led by Dr. Charles Hensley, the Inventor of Zicam® Cold Remedy, Received FDA Labeler Status 7/31/2013  More...
FDA Can't Allow Execution Drug to be Imported 7/24/2013  More...
Urine, Lies and a Wayward Drugmaker: FDA Tells Off Wockhardt 7/24/2013  More...
FDA Performs Re-Inspection of Albany Molecular Research, Inc. (AMRI) (AMRI) Burlington MA Facility 7/23/2013  More...
Kiadis Pharma to Receive GMP Manufacturing License and GMP Certificate 7/23/2013  More...
Yukon Medical, LLC. Receives ISO 13485 Certification 7/22/2013  More...
Drugmaker Fees for FDA Review Would be Freed in U.S. House Bill 7/19/2013  More...
Cispharma Inc.: Unapproved Drugs, Faulty Tablets, Bloody Accident Lead to Warning Letter for Generics Company 7/18/2013  More...
Analogic Corporation (ALOG)'s COBRA Checkpoint CT System Receives ACBX Approval From the United Kingdom Department for Transport 7/18/2013  More...
Oncodesign SA Awarded Accreditation of Its Research Center by International Association, AAALAC 7/18/2013  More...
Musculoskeletal Transplant Foundation -- First Tissue Bank to Receive Approvals to Market Allografts in Australia 7/12/2013  More...
Regulatory Affairs Professionals Society Webcast to Examine Risk Management in Healthcare Product and Process Quality 7/10/2013  More...
Wockhardt Barred From Making Drugs for Europe 7/10/2013  More...
Datamonitor Release: AMNOG May Cause Havoc in German Diabetes Market - Analyst Opinion 7/9/2013  More...
Eli Lilly and Company (LLY): Centers for Medicare & Medicaid Services Wants More Amyvid Trials Before Approving Medicare Coverage 7/8/2013  More...
Morphotek Inc. Achieves LEED® Certification for New Pilot Plant 7/8/2013  More...
Genethon, the French AFM-Telethon Laboratory, Becomes the First Not-for-Profit to Obtain Authorization From ANSM to be a Pharmaceutical Manufacturer 7/8/2013  More...
Generex Biotechnology Corporation (GNBT) Announces Amendment of Form S-1 7/3/2013  More...
Tianyin Pharmaceutical Co, Inc.'s Qionglai Facility (QLF) Pre-extraction Plant Scheduled for GMP Inspection 7/2/2013  More...
NanoViricides, Inc. (NNVC.PK) Submits DengueCide™ Orphan Drug Designation Letter of Intent to File With the European Medicines Agency 7/1/2013  More...
End of a Dark Era? National Institutes of Health (NIH) to Retire Most Research Chimps 6/27/2013  More...
EntreMed, Inc. (ENMD) Files New Drug Global Clinical Trial Application for ENMD-2076 With China CFDA to Expand Clinical Trial for Advanced/Metastatic Sarcoma 6/27/2013  More...
India Upholds Cancellation of Johnson & Johnson (JNJ) Plant License 6/25/2013  More...
DiaTech Oncology Receives New York State Clinical Laboratory Permit 6/25/2013  More...
Ranbaxy Laboratories (RANBAXY.BO), Another Bad FDA Report & the Missing Generic Diovan 6/25/2013  More...
FDA Grants Fast Track Designation to Rebiotix for Its Microbiota Product for Recurrent Clostridium difficile Infection 6/24/2013  More...
Advaxis, Inc. Requests Orphan Drug Designation for Treatment of HPV-Associated Anal Cancer With ADXS-HPV 6/24/2013  More...
Sanofi (France) (SAN.PA) CEO: EU Open Data Plan Would Hurt Drugmakers 6/24/2013  More...
The FDA's Cancer Czar Says He Can't Approve New Drugs Fast Enough 6/24/2013  More...
Total Recall? China Chastises Johnson & Johnson (JNJ) Over Its Product Recall Policy 6/20/2013  More...
SCM Pharma Limited Release: Medicines and Healthcare Products Regulatory Agency Approval for CDMO's Commercial Facility 6/19/2013  More...
Regulatory Affairs Professionals Society Opens Offices in Singapore and China 6/18/2013  More...
ADMA Biologics, Inc.’s Plasma Collection Facility Receives GHA Certification for the Sale of Source Plasma in Europe 6/18/2013  More...
European Medicines Agency's Management Board Endorses Revised EMA Code of Conduct 6/17/2013  More...
IntelliCell BioSciences (SVFC) Announces That Its Cellular Tissue Laboratory Was Inspected by FDA 6/14/2013  More...
ValGenesis, Inc. Receives Safe Harbor Privacy Compliance Certificate for On Demand Services From U.S. Department of Commerce 6/13/2013  More...





 

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