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

The entities involved

• FDA →
  • Regeneron, the FDA, and research institutions are advancing the Ebola response in the DRC through drug approvals and clinical trials.05:37
  • Granules India Limited is submitting ANDA and Paragraph IV certification to the FDA.03:54
• European Medicines Agency →

  highest regulatory authority on medicines in the European Union

  • The European Medicines Agency is reviewing mRNA vaccine trials reported by Moderna and MSD.Sat 03:31
  • EMA adopted a negative opinion on MAA for Omeros Corporation, while Pomerantz LLP confirmed its global office locations.Thu 15:51

Related events

• Both the FDA and the European Medicines Agency govern drug approval processes.Aug 12
• Both the FDA and European Medicines Agency must adopt evidence-based principles for drug regulation.Oct 16
• New FDA rule threatens the ability to import medicines.Oct 18
• A company is conducting clinical trials and seeking drug approval for the U.S. market under the FDA.Jun 7
• Congress and the Senate are considering legislation affecting FDA submissions and drug patent rights.Oct 21