Regulatory Affairs Professionals Society Opens Offices in Singapore and China
6/18/2013
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ADMA Biologics, Inc.’s Plasma Collection Facility Receives GHA Certification for the Sale of Source Plasma in Europe
6/18/2013
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European Medicines Agency's Management Board Endorses Revised EMA Code of Conduct
6/17/2013
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IntelliCell BioSciences (SVFC) Announces That Its Cellular Tissue Laboratory Was Inspected by FDA
6/14/2013
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ValGenesis, Inc. Receives Safe Harbor Privacy Compliance Certificate for On Demand Services From U.S. Department of Commerce
6/13/2013
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Swedish Orphan Biovitrum Gets FDA Approval to Manufacture Substance for Kineret® With Partner Boehringer Ingelheim Corporation
6/11/2013
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Elite Laboratories, Inc. (ELI) Files Citizen Petition With the FDA on Brompheniramine Maleate and Pseudoephedrine HCL Extended Release
6/11/2013
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Phyton Biotech, Inc. Receives CEP for Docetaxel API
6/10/2013
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AMAG Pharmaceuticals, Inc. (AMAG) Announces Submission of a Type II Variation for Rienso Label Expansion in Europe to Include All Adult Iron Deficiency Anemia Patients Who Cannot Take Oral Iron
6/7/2013
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EU to Fine Lundbeck Inc. (LUN.CO), Others for Blocking Generic Drugs
6/4/2013
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DSP Clinical Research Earns Certification as Women's Business Enterprise (WBE) From Women's Business Enterprise National Council
6/4/2013
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Clinical CRO ICRC-Weyer to Boost Drug Safety Services for Investigator Trials
5/31/2013
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Johnson & Johnson (JNJ) Pleads Maha FDA to Revoke Suspension of Licence
5/29/2013
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Doc Claims SummerStreet's Amarin Corporation PLC (AMRN) Report is Inaccurate
5/29/2013
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TWi Pharmaceuticals, Inc.' Manufacturing Site for the Generic Version of Lidoderm(R) (Lidocane 5% patch) Passes US FDA cGMP Audit and Pre-Approval Inspection
5/29/2013
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More Trouble for Ranbaxy Laboratories (RANBAXY.BO) as Drug Boycott to Continue
5/29/2013
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Sinovac Beijing Obtains China GMP Certificate Under the New GMP Guidelines
5/28/2013
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Norgine Release: PBAC Approves XIFAXAN® (Rifaxamin a) 550 mg Cost Effectiveness in Australia
5/28/2013
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What Patient Harm? FDA Slams Shionogi, Inc. for Not Preparing Studies
5/28/2013
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AB SCIEX Improves Food Safety With New Method to Identify Markers for Horse Meat and the Banned Veterinary Drug Residue Phenylbutazone
5/23/2013
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A Boehringer Ingelheim Corporation Shake Up and an FDA Warning Letter Over Production Gaffes
5/23/2013
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Ranbaxy Laboratories (RANBAXY.BO) Highlights Improved Business and Quality Assurance Standards
5/22/2013
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Lonza Inc. Issues Guidance on Infection Control and Global Influenza A (H7N9)
5/22/2013
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IMPAX Laboratories, Inc. (IPXL) Board Steps in to Oversee Hayward Manufacturing Issues
5/21/2013
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Biotrial Bioanalytical Services (Bbs) Proves Top-Quality Performance by Successfully Passing Another FDA Inspection
5/13/2013
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FDA Releases Alexion Pharmaceuticals Inc. (ALXN) Response to 483 Report
5/9/2013
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Tekmira Pharmaceuticals Corporation Provides Update on U.S. Government Sponsored TKM-Ebola Program
5/8/2013
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Clinovo Launches Its TechTraining on CDISC Standards
5/8/2013
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Another Biosimilar Legislative Defeat for Amgen (AMGN) & Genentech (RHHBY)
5/7/2013
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Spectranetics Corporation (SPNC) Finalizes EXCITE ISR Adjunct Analysis Plan
5/7/2013
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Ajinomoto’s North Carolina Plant Receives ISO 9001 Certification
5/6/2013
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Johnson & Johnson (JNJ) Licence Revoked Over Baby Powder Concerns
5/6/2013
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BioIndustry Association Meeting Highlights Benefits of the Patent Box to Life Science Companies
5/2/2013
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Tauriga Sciences Inc. (TAUG) Enhances Its Corporate Governance Protocols Through the Establishment of Four Board Oversight Committees and Corporate Code of Ethics
4/26/2013
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Immunotech Laboratories Begins Regulatory Process With FDA
4/26/2013
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Regulatory Affairs Professionals Society Virtual Program on Advertising, Promotion and Labeling for Drugs and Devices to Cover Federal Trade Commission and FDA Enforcement, Social Media, Sunshine Act and More
4/23/2013
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FDA Scolds Teva Pharmaceutical Industries Limited (TEVA) for an Unbalanced and Overblown Handout
4/23/2013
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Biosearch Technologies Launches New GMP Production Facility and Successfully Certifies to ISO 13485:2003
4/18/2013
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La Jolla Pharmaceutical Company (LJPC) Receives Orphan Designation From FDA for LJPC-6417
4/18/2013
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Second ISPE-FDA Event Attracts Top Names, Features Release of Drug Shortage Survey Results
4/17/2013
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Omeros Corporation (OMER) Files Orphan Drug Application for Treatment of Atypical Hemolytic Uremic Syndrome With OMS721
4/17/2013
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FDA Requests $4.7 Million for China Drug Maker Inspections
4/12/2013
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Waiter, There's Cardboard in My Sample: FDA Warns Pfizer Inc. (PFE) Over Manufacturing Gaffes
4/12/2013
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Regulatory Affairs Professionals Society Webcast to Examine China SFDA Device Registration Process
4/9/2013
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ISPE Releases New Guidance for Standardizing Use of Booklet Labels in Global Clinical Trials
4/4/2013
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Alliance Life Sciences Empowers International Reference Pricing for Pharmaceutical Manufacturers Worldwide With PRICENTRIC™ - Global Pricing Data and Advanced Analytics
4/4/2013
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Bioheart, Inc. Completes FDA Registration for Tissue Bank Establishment
4/2/2013
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China Cord Blood Corporation Received AABB Accreditation
4/2/2013
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Vetter's Newest Facility Successfully Completes FDA Inspection
3/28/2013
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FDA Lifts Import Alert on Aurobindo Pharma's Hyderabad Facility
3/28/2013
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AIBioTech Receives Laboratory Permit From the New York State Department of Health to Perform Clinical Testing
3/28/2013
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Bioheart, Inc.'s Appeals to the FDA for Compassionate Use Designation to Save Lives
3/27/2013
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Vetter's Newest Facility Successfully Completes FDA Inspection
3/27/2013
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Recipharm AB Site in France Approved for Supply of Manufactured Products to Japan
3/26/2013
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Translational Genomics Research Institute (TGen) Establishes Secure Link to 2nd Supercomputer With "Obsidian Longbow™" Technology
3/26/2013
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Isis Pharmaceuticals, Inc. (ISIS) Provides Update on CHMP Opinion on KYNAMRO™ (Mipomersen)
3/25/2013
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Cook Pharmica LLC Receives an Additional Commercial Approval From FDA
3/25/2013
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PPD, Inc. (PPDI)'s Bioanalytical Labs Certified as a Center of Bioavailability/Bioequivalence of Medicines by Brazil's National Health Surveillance Agency
3/22/2013
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NDIS Approval of Promega Corporation PowerPlex® Fusion System Assists Laboratories in Meeting Evolving Standards
3/22/2013
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Baxter International, Inc. (BAX) and Halozyme Therapeutics, Inc. (HALO) Announce Positive Opinion for HyQvia for Treatment of Primary and Secondary Immunodeficiencies in the European Union
3/22/2013
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GENEWIZ, Inc. Receives CAP Accreditation
3/21/2013
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FDA Advisory Committee Votes Favorably on Abbott Laboratories (ABT)'s Minimally Invasive MitraClip® Device for Patients with Significant Mitral Regurgitation Who are Too High Risk for Surgery
3/21/2013
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Link Technologies Ltd Release: New Cyanine Dyes Reduce Time and Cost of Oligo Labelling
3/20/2013
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Hospira, Inc. (HSP) Obtains Six Months U.S. Pediatric Exclusivity for Precedex™ (dexmedetomidine HCl) Injection
3/19/2013
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Butamax™ Advanced Biofuels LLC. Announces Immediate Appeal of Court Decisions on Claim Construction and Summary Judgment
3/19/2013
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Cytomedix Inc. (CMXI) Announces Centers for Medicare & Medicaid Services Issuance of Reimbursement Coding for Autologous PRP in Chronic Non-Healing Wounds
3/18/2013
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Echo Therapeutics (ECTE) Achieves ISO 13485 Certification
3/15/2013
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Masy Systems, Inc. Now NVLAP Accredited to Perform RH Calibrations
3/15/2013
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Pfizer Inc. (PFE) Criticizes India's Intellectual Property Policies
3/14/2013
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Deadline Approaches for ISPE Drug Shortage Survey
3/14/2013
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Regulatory Affairs Professionals Society, Singapore to Collaborate on First Medical Device Regulatory Training Program in Southeast Asia
3/14/2013
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Cardium Therapeutics, Inc. (CXM) Receives ISO Certification for Excellagen
3/14/2013
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Sheldon Manufacturing, Inc. is Now ISO 9001:2008 Certified
3/14/2013
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SFDA to Monitor Food Safety; Will Remain Part of Ministry of Health
3/13/2013
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FDA Finds Problems Continue at IMPAX Laboratories, Inc. (IPXL) Factory in Hayward
3/6/2013
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IMPAX Laboratories, Inc. (IPXL) Provides an Update on FDA Inspection of Hayward Facility
3/5/2013
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China to Give SFDA Responsibility for Food as Well as Drugs
3/5/2013
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GlySure Earns ISO 13485 Certification
3/5/2013
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GENOMAS LLC Expands Personalized Medicine Business With Clinical Laboratory Licenses in New York, Florida, California
3/4/2013
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Biotage AB (BIOTa.ST): Food Contact Notification to FDA
3/4/2013
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Aris Global, LLC Delivers the World's Only In-Use Global Safety Solution
3/4/2013
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Intralytix, Inc. Wins Regulatory Approval for Phage-Based Food Safety Product Effective Against Salmonella
2/28/2013
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Regulatory Affairs Professionals Society Medical Device Submission and Compliance Workshop to Feature FDA Regulators, Industry Experts
2/28/2013
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Regulatory Affairs Professionals Society Release: 338 Earn Regulatory Affairs Certification in Autumn 2012
2/27/2013
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US BioDesign Awarded International Organization for Standards(ISO) 13485 Certification
2/26/2013
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FDA Official Rick Friedman to Present Plenary at ISPE Aseptic Education Intensive
2/21/2013
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Almac Group Receives FDA Inspection Approval
2/20/2013
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YaFarm Technologies Announces ISCI IRB Submission
2/15/2013
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Cellular Biomedicine Group Announces ISO 9001:2008 Certification and ISO-14644 Cleanroom Certification
2/15/2013
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Evogene Ltd. Announces Launch of Model Plant Validation System for Monocot Plants
2/13/2013
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New PoMaxa™ Plant Growth Regulator From Valent BioSciences Corporation Receives EPA Registration
2/12/2013
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ISPE Releases New Guidance for Definition and Use of Non-Investigational Medicinal Products in Clinical Trials
2/7/2013
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Regulatory Affairs Professionals Society, CPC to Offer Workshop on FDA's Final Rule on Manufacturing of Combo Products
2/7/2013
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Almac Group Launches U.S. Commercial Packaging Operations With Successful FDA Inspection and New Client Partnership
2/6/2013
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GlaxoSmithKline (GSK) Clashes With Pharmaceutical Research and Manufacturers of America (PhRMA) Over Data Disclosure
2/5/2013
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NDIS Approval of the Promega Corporation PowerPlex® Y23 System Enables More Usable Profiles in Less Time
2/5/2013
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Rafarma Pharmaceuticals, Inc. Receives General License for Pharmaceutical Products and Has Started to Manufacture 3 New Products
2/4/2013
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FDA Extends License of the gvk bioSciences Private Limited Biomarker Database
2/4/2013
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Boehringer Ingelheim Corporation Ohio Drug Plant Shut by U.S. on Quality Issues
2/1/2013
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European Commission (EC) Study Finds UK Health Product Benefit Metric Flawed
1/31/2013
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Bend Research Receives EU Certificate of GMP Compliance
1/30/2013
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TiGenix Successfully Renews GMP License for Stem Cell Manufacturing Facility in Madrid
1/29/2013
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First DataBank Inc. Releases State and Federal Controlled Substances Module™
1/28/2013
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Aoxing Pharmaceutical Company Inc. (AXN) Announces Receipt of Production License for Pholcodine
1/28/2013
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Sartorius Stedim Biotech's New Manufacturing Facility in Yauco, Puerto Rico, Receives LEED Platinum Certification
1/25/2013
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Troubled Boehringer Ingelheim Corporation Unit Gets a Consent Decree
1/23/2013
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ChinaBio(R) LLC Release: China Proposes Fast-Track Approvals for Innovative Drugs
1/18/2013
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Applied DNA Sciences, Inc. (APDN) to Provide Unique DNA Mark to Forward Components, Inc. for DNA-Marking of Microcircuits
1/17/2013
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ISPE Updates and Expands Guidance for Testing of GxP Systems
1/17/2013
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BioStorage Technologies, Inc. Receives CAP Accreditation for U.S. Biorepository Facility
1/16/2013
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China Botanic Pharmaceutical Inc. (Formerly known as Renhuang Pharmaceuticals Inc.) Announces Receipt of Warning Letter
1/15/2013
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Genea Stem Cells (GSC): 25 New Disease Specific Pluripotent Stem Cell Lines Placed on the National Institutes of Health (NIH) Registry
1/14/2013
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FDA Might Tighten Reins on Vicodin
1/11/2013
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Transcept Pharmaceuticals, Inc. (TSPT) Comments on New FDA Dosage Reduction Requirements for Zolpidem Based Prescription Sleep Aids Administered at Bedtime
1/11/2013
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Melbourn Scientific Awarded Manufacturer's / Importer's Authorisation (MIA)
1/9/2013
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Perrigo Company (PRGO) Gains FDA Clearance to Manufacture Three Codex-Compliant Infant Formulas to Meet Growing Demand From International Markets
1/7/2013
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Paratek Pharmaceuticals, Inc. Announces FDA Grant of Qualified Infectious Disease Product (QIDP) Designation for Its Lead Product Candidate, Omadacycline
1/4/2013
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Ranbaxy Laboratories (RANBAXY.BO) Implements Cegedim Relationship Management's Compliance Solution Suite to Efficiently Meet Regulatory Requirements
1/4/2013
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China Biologic Products's Guizhou Taibang Subsidiary Announces Update Regarding GMP Upgrading
1/2/2013
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AITbiotech Secured CE-IVD Certification for Its Influenza (Flu) and Mycobacteria Tuberculosis (MTB) Molecular Diagnostic Assays
1/2/2013
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Bioplast Manufacturing, LLC Achieves ISO 9001:2008 Certification
12/28/2012
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European Medicines Agency Documents Are "Secret No Longer"
12/21/2012
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Exponent Inc. (EXPO) Release: Failure Analysis, Product Recalls, and Liability: Preventative Measures to Help Prevent the FDA From Knocking on Your Door
12/20/2012
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Bioniche Life Sciences Inc. (BNC) Achieves Registration of Enhance™ I.A./I.V. in Hong Kong
12/14/2012
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Quintiles, Inc. (QTRN) Central Laboratory Receives First Industry Accreditation Dedicated to Biorepository Program
12/14/2012
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Gyros AB Quality Management System Receives ISO 9001:2008 Certification
12/13/2012
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Vetter Receives “Known Consignor” Approval From Germany's Federal Aviation Office
12/11/2012
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Cellon SA Release: PharmaTainer™ Single Use Bottles and Carboys Now Meet USP 788
12/11/2012
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Vetter Receives "Known Consignor" Approval From Germany's Federal Aviation Office
12/11/2012
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WorldCare Clinical, Inc. Publishes Guidance on Defining the Process for Independent Endpoint Review Services in Clinical Trials
12/10/2012
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FDA Grants Orphan Drug Designation to Biodel Inc. (BIOD)l's Glucagon for Prevention of Hypoglycemia in Congenital Hyperinsulinism Population
12/7/2012
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Covance Inc. (CVD) Receives SFDA GLP Certification for Its Early Development Facility in Shanghai, China
12/4/2012
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Next Generation Sequencing of GATC Biotech Accredited by German DAkkS
12/3/2012
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Covance Inc. (CVD) Receives SFDA GLP Certification for Its Early Development Facility in Shanghai, China
12/3/2012
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ISPE Approved as Registered Education Provider by Project Management Institute
11/29/2012
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Pfizer Inc. (PFE) Release: World Health Organization Makes Prevnar 13 Available to Adults 50+
11/21/2012
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Fastest Spent Media Analysis Validated against ICH Guidelines: Spinnovation Biologics' Spedia-NMRTM Meets Stringent Pharma Guidelines
11/20/2012
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The FDA Workforce & a "Broken" Hiring System
11/20/2012
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Parmatech Receives ISO 9001:2008 Certification for Its Rhode Island Facility
11/19/2012
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PolyMedix Inc. (PYMX.OB) Announces Successful Meeting With FDA for Brilacidin
11/16/2012
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IntelliCell BioSciences (SVFC) Issues Corrected Listing For Human Cells, Tissues, and Cellular Based Products
11/15/2012
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SNBL USA, Ltd. Announces Official Letter From the FDA Declaring All Issues Resolved
11/14/2012
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FDA Clears Ikaria Inc.'s INOMAX® DSIR to Connect With Hospital Health Information Systems
11/13/2012
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FDAnews Announces Preparing for the New Electronic Submission Mandates
11/13/2012
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Ranbaxy Laboratories (RANBAXY.BO) to Get Guidance Soon for Remedial Steps on Dewas Unit
11/12/2012
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Mobius Theraputics™ Announces Assignment of HCPCS Code for Mitosol®
11/8/2012
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Regulatory Affairs Professionals Society and China's SFDA to Collaborate on Regulatory Education and Training
11/8/2012
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FDA Designates Durata Therapeutics, Inc. ' Dalbavancin a Qualified Infectious Disease Product (QIDP)
11/5/2012
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eClinicalWorks is Fully NCQA Certified as a CAHPS PCMH Survey Vendor
11/5/2012
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Doe & Ingalls Management, LLC Receives Distilled Spirits Plant Permit in its California, Maryland & North Carolina Locationsd
11/5/2012
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Advanced Cell Diagnostics, Inc. Announces Data and Safety Monitoring Board (DSMB) Approval to Complete Second Patient Cohort in Clinical Trial for Dry AMD
11/1/2012
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Orgenesis Presents Technology Update to FDA/CBER Experts
10/29/2012
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StemCyte, Inc.'s Global Leadership & Quality Standards Continue
10/26/2012
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China Biologic Products Receives GMP Certificate for Human Coagulation Factor VIII to Start Commercial Manufacturing This Month
10/25/2012
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MicroTest Laboratories Release: New White Paper Assists Medical Device Manufacturers With Changes to FDA Endotoxin Testing Guidelines
10/25/2012
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Aptuit, Inc. Offers Design, Implementation and Analysis of Phase I Standard and Fusion Studies
10/25/2012
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Sequenta Earns CLIA Certification
10/24/2012
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Journal Stem Cell Translational Medicine to Publish Article on FDA Communications and the Regulatory Pathway for Cell-Based Therapies
10/18/2012
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VIVUS, Inc. (VVUS) Submits REMS Amendment to FDA for Qsymia (Phentermine and Topiramate Extended-Release) Capsules CIV
10/17/2012
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FDA Warns Celltex Therapeutics Corporation Over Violations
10/17/2012
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SNBL USA, Ltd. Receives AAALAC Accreditation for Its Facilities in Wash. and Texas
10/16/2012
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AITbiotech Secured ISO 13485 Certification for Its Genomic Services and MDx Labs in Singapore
10/15/2012
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CorMedix (CRMD) Successfully Completes and Passes ISO 13485 Certification Audit
10/11/2012
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Marken (Formerly known as Marken Time Critical) Reconfirmed as C-TPAT Compliant
10/11/2012
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Biotechnology Industry Organization (BIO) Strongly Opposes RFS Waiver Requests in Comments to EPA
10/10/2012
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Rib-X Pharmaceuticals, Inc. Receives Qualified Infectious Disease Product (QIDP) Designation From the FDA for Radezolid
10/10/2012
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FDA Inspects MicroConstants for Compliance With Good Laboratory Practices, No Deficiencies Noted
10/9/2012
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SEC Investigates Pfizer Inc. (PFE) Over Odd Results
10/9/2012
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Genetic Immunity Receives GMP Certification for in-House Manufacturing Facility
10/8/2012
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China National Biotech Group May Soon Sell Vaccine to International Aid Groups
10/5/2012
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IntelliCell BioSciences (SVFC) Announces Research Tissue Bank License
10/4/2012
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AcelRx Pharmaceuticals Receives Notice of Eligibility for Centralized Review From European Medicines Agency for the Sufentanil NanoTab® PCA System
10/3/2012
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BayBio (Bay Area Bioscience Association) and BIOCOM Commend Passage of AB 1277 to Reduce Redundant Facilities Inspections for Life Science Companies
10/2/2012
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Senomyx, Inc. (SNMX) Receives Generally Recognized as Safe (GRAS) Determinationa for New S9632 Flavor Ingredient
10/1/2012
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Case Study: Accurate Pharma Package Inspection Amcor
10/1/2012
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Osiris Therapeutics, Inc. (OSIR) Release: Swissmedic Invokes Rapid Authorization Procedures for Prochymal Review
9/28/2012
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Roka Bioscience, Inc. Receives AOAC-RI Certification for 10 Additional Salmonella Matrices
9/27/2012
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Successful MHRA Inspection of Almac Group’s Clinical Services UK Facility
9/26/2012
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Successful MHRA Inspection of Almac Group's Clinical Services UK Facility
9/26/2012
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Summit Corporation Receives Regulatory Approval to Commence Phase I Clinical Trial of Selective Antibiotic for the Treatment of C. Difficile Infections
9/25/2012
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Mustard Tree Instruments Announces Hazardous Location Certification for VPS-1000 In-Process Material Verification Tool
9/25/2012
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Boston Therapeutics, Inc. Announces Filing of S-1 Registration Statement
9/24/2012
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Colorcon, Inc. Quality by Design (QbD) Expertise Beneficial in Compliance With New FDA Guidelines
9/21/2012
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ISPE Releases New Guidance for Designing Pharmaceutical Quality Laboratory Facilities
9/19/2012
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Sinovac Biotech Ltd. (SNVBF) Receives GMP Certification for Mumps Vaccine Production Facility
9/18/2012
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GPMG's Modularized ISO 13485 FDA QSR Compliant Quality Management System
9/18/2012
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Recipharm Monts Secures Regulatory Approval From ANSM to Fill Biotech Products
9/17/2012
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Rib-X Pharmaceuticals, Inc. Receives Qualified Infectious Disease Product (QIDP) Designation From the FDA for Delafloxacin
9/17/2012
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Celerion is the First CRO Headquartered in the USA to Receive Full Accreditation From AAHRPP
9/17/2012
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FDA Warns L'Oreal's Lancome Unit on Anti-Wrinkle Product Marketing
9/12/2012
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FDA Drug Review Deal Set to Unravel as Fiscal Cliff Looms
9/11/2012
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RayBiotech Achieves Both GMP- and GLP-Compliance and Announces New Dedicated Services Laboratory
9/5/2012
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FDA Lifts Ban on Indian Pharma, Including Sun Pharmaceutical Industries Ltd and Dr. Reddy's Laboratories Ltd. (RDY), After Fixing Problems
9/4/2012
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Biocitech SAS Resident OCT Sante Obtains Official Certification for Innovative Thermal Packaging Models for the Transport of Biological Samples
9/4/2012
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Takeda Pharmaceutical Co. Ltd. (TKDG.DE) Release: Companies Submit Joint Application Seeking Approval for Additional Indication for Helicobacter pylori
8/31/2012
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MicroConstants China's New Facility Passes OECD GLP Compliance Inspection
8/28/2012
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Caraco Pharmaceutical Laboratories, Ltd. (CPD) Gets FDA Nod to Resume U.S. Operations
8/28/2012
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Northwest Biotherapeutics (NWBT) Receives Regulatory Approval to Proceed With Its Phase III Trial in the UK
8/23/2012
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New England Biolabs, Inc. Achieves ISO 14001 Recertification in Recognition of Its Commitment to Environmental Management
8/23/2012
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Alexza Pharmaceuticals, Inc. (ALXA) Receives EU Certificate of GMP Compliance for its ADASUVE™ Manufacturing Facility
8/22/2012
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