Omega Therapeutics (OMGAQ) FDA Events

No FDA events found for this company in the last two years.

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FDA Event Stage Terminology & Abbreviation Guide

• NDA: New Drug Application
• ANDA: Abbreviated New Drug Application
• sNDA: Supplemental New Drug Application
• BLA: Biologics License Application
• sBLA: Supplemental Biologics License Application
• FDA Approved: Approved by the FDA
• EMA: European Medicines Agency
• CE Mark: European Union Certification
• NMPA: China National Medical Products Administration
• MHLW: Japanese Ministry of Health
• FDA Meeting: Consultation with FDA
• Pre-IND: Pre-Investigational New Drug Meeting
• Breakthrough Therapy: Special FDA designation for promising therapies
• Fast Track: Accelerated FDA approval pathway
• Orphan Drug: Designation for rare disease treatments
• RPD: Rare Pediatric Disease Designation
• RMAT: Regenerative Medicine Advanced Therapy
• DSMB Review: Data Safety Monitoring Board Review
• IDMC Review: Independent Data Monitoring Committee
• MAA: MHRA Marketing Authorization Application
• RTF: Refusal to File (Rejected Application)
• 510(k): FDA Clearance for Medical Devices
• Rolling Submission: Staggered regulatory review process