The FDA and European Medicines Agency are harmonizing regulatory review of drug applications.

The entities involved

• FDA →
  • Generic medicine services are seeking approval for launch from the FDA.Mon 17:49
  • A company is seeking FDA feedback on its NEO212 program, with a meeting scheduled at the FDA's White Oak campus.Mon 14:56
• European Medicines Agency →

  highest regulatory authority on medicines in the European Union

  • IGC Pharma, Inc. is preparing data for potential U.S. FDA review and seeking EMA support for its lead drug candidate.Mon 14:18
  • Both the FDA and the European Medicines Agency are evaluating NervGen's lead therapeutic candidate.Fri 23:04

Related events

• Both the FDA and the European Medicines Agency govern drug approval processes.Aug 12
• The FDA is currently reviewing new drug applications for market entry.Jun 22
• The FDA recommended advancement for a new drug application submitted by a company.Jun 8
• The FDA is reviewing drug data and company resubmissions, while also overseeing the functions of the U.S. Department of Health and Human Services.Aug 14
• Humane World for Animals petitioned the FDA and lobbied Congress regarding drug approval regulations.Sep 22