• Medical Translation
    • Medical Translation Services
      • COVID-19 Emergency Response Team
      • CTD/eCTD Submission
      • Linguistic Validation
      • eLearning & Training
      • Back Translation
      • Creative Communication
      • Terminology Management
      • Software Localization
      • Medical Document Translation Services
      • Linguistic Testing
      • Machine Translation Post-Editing
      • In-Country Review
      • Multilingual Desktop Publishing (DTP)
      • Technical Translation
      • Pharmacovigilance
      • Clinical Studies
      • Patient Recruitment
  • Industries
    • Medical Devices
    • Hospital Translation
    • Chemical Translations
    • In-Vitro Diagnostic Devices
    • Pharmaceuticals
    • Biotechnology
    • Health Science Legal Translation Services
    • Government, NGO & Non-Profit
  • Interpretation
    • Interpretation Services
      • CDE Pre IND/NDA Meeting
      • Medical Conferences
      • Phone Interpretation
      • Video Interpretation
  • Executive Management
  • HealthFirst 100
    • About HealthFirst 100
      • Health
      • Articles
      • News
      • White Papers & Case Studies
  • CSOFT International
  • English
    • 简体中文
    • Español
  • CSOFT International
  • News & Events
  • Careers
  • Contact
  • English
    • 简体中文 (Chinese (Simplified))
    • Español (Spanish)
  • CSOFT International
  • CSOFT International
  • CSOFT International
  • CSOFT International
CSOFT Health Sciences
  • Medical Translation
    • Medical Translation Services
      • COVID-19 Emergency Response Team
      • CTD/eCTD Submission
      • Linguistic Validation
      • eLearning & Training
      • Back Translation
      • Creative Communication
      • Terminology Management
      • Software Localization
      • Medical Document Translation Services
      • Linguistic Testing
      • Machine Translation Post-Editing
      • In-Country Review
      • Multilingual Desktop Publishing (DTP)
      • Technical Translation
      • Pharmacovigilance
      • Clinical Studies
      • Patient Recruitment
  • Industries
    • Medical Devices
    • Hospital Translation
    • Chemical Translations
    • In-Vitro Diagnostic Devices
    • Pharmaceuticals
    • Biotechnology
    • Health Science Legal Translation Services
    • Government, NGO & Non-Profit
  • Interpretation
    • Interpretation Services
      • CDE Pre IND/NDA Meeting
      • Medical Conferences
      • Phone Interpretation
      • Video Interpretation
  • Executive Management
  • HealthFirst 100
    • About HealthFirst 100
      • Health
      • Articles
      • News
      • White Papers & Case Studies
  • CSOFT International
  • English
    • 简体中文
    • Español
Select Page
FDA Places Interim Process to Communicate Issues Found During Record Reviews

FDA Places Interim Process to Communicate Issues Found During Record Reviews

Feb 3, 2021 | Clinical Trials, FDA, News, Regulatory

The U.S. Food and Drug Administration (FDA) has outlined an interim process for drug developers to relay any problems identified during record reviews instead of, or in advance of, preapproval inspections. Their responses will be taken into consideration before action...
FDA Advisory Committee Passes Alkermes’ Schizophrenia Drug

FDA Advisory Committee Passes Alkermes’ Schizophrenia Drug

Oct 12, 2020 | News, Regulatory

The U.S. Food and Drug Administration (FDA) Advisory Committee voted 16-1 in favor of passing Alkermes’ schizophrenia and bipolar disorder treatment drug (AKMS 3831). FDA members voiced concern about the potentially addictive qualities of the drug, as it contains an...
Despite Advisory Committee’s Approval, FDA Rejects Mesoblast’s Ryoncil

Despite Advisory Committee’s Approval, FDA Rejects Mesoblast’s Ryoncil

Oct 2, 2020 | News, Regulatory

Today (10/2) the U.S. Food and Drug Administration (FDA) announced the rejection of Ryoncil, a treatment for steroid-refractory acute graft versus host disease (SR-aGVHD) in pediatric patients. For patients with the most aggressive form of SR-aGVHD, the mortality rate...
FDA Grants Approval to Laurent Pharmaceuticals to Start COVID-19 Phase 2 Clinical Trial in the United States

FDA Grants Approval to Laurent Pharmaceuticals to Start COVID-19 Phase 2 Clinical Trial in the United States

Aug 28, 2020 | News, Regulatory

Laurent Pharmaceuticals, a Montreal based clinical stage biopharmaceutical company has come up with an oral drug candidate, LAU-7b, to potentially treat COVID-19. The U.S. Food and Drug Administration (FDA) has granted Laurent Pharmaceuticals to begin enrolling U.S....
Lowering Prescription Drug Prices for Affordability and Accessibility for US Citizens

Lowering Prescription Drug Prices for Affordability and Accessibility for US Citizens

Aug 21, 2020 | Clinical Trials, FDA, Globalization, Healthcare, Pharmaceuticals

One of the biggest areas of concern in the pharmaceutical industry, particularly in the United States, is the high costs of new treatments or drug therapies for patients. The recent initiatives from regulatory agencies like the Food and Drug Administration (FDA) to...
Page 1 of 212»

Recent Posts

  • FDA Clears IND Application for Flexion Therapeutics’ FX301
  • FDA Approves Targeted Treatment for Duchenne Muscular Dystrophy
  • FDA Partially Rescinds Two Supplemental Biologics License Applications
  • Sinopharm Unit and CanSinoBio apply for Public Use Approval of COVID-19 Vaccine in China
  • FDA Makes Recommendations for COVID-19 Variants

Topics

  • CFDA
  • Classification System
  • Clinical Trials
  • e-Labeling
  • e-Learning
  • EMA
  • Events
  • FDA
  • Globalization
  • Health
  • Healthcare
  • In-Country Review
  • Innovation
  • Interpretation
  • Language Service Provider
  • Linguistic Validation
  • Machine Translation
  • Medical Translation
  • Medical Writing
  • Mistranslations
  • Mobile Translation
  • News
  • Pharmaceuticals
  • Quality
  • Regulatory
  • Resources
  • Social Media
  • Special stories
  • Terminology
  • Transcreation
  • Website Translation
  • Translation
  • CTD/eCTD Submission
  • Clinical Studies
  • Clinical Trials
  • Linguistic Validation
  • Back Translation
  • Medical Writing
  • eLearning & Training
  • Creative Communication
  • Terminology Management
  • Interpretation
  • CDE Pre IND/NDA Meeting
  • Medical Conferences
  • Over the Phone
  • Medical Writing
  • Regulatory Writing
  • Medico-Marketing
  • Publication Writing
  • Medical Writing Safety Writing
  • Lay Summaries
  • Informed Consent Form Translation
  • Patient Safety Narratives
  • Advisory Boards
  • Summaries of Safety
  • Asia Regulatory Services
  • Asia Market Access
  • Asia Regulatory Strategy
  • Clinical Trials in Asia
Environmental Responsibility and Sustainability at CSOFT
    ISO 9001 and ISO 13485 Certified © 2021 CSOFT International, Inc.    Terms of Use    Privacy Policy