CDER SBIA Webinar: Updates to Forms 356h & 1571: Commercial vs. Research, SNOMED CT, Combination Products - Drug Information Update

Updates to Forms 356h & 1571: Commercial vs. Research, Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT), Combination Products

On May 4th, FDA updated FDA Forms 356h and 1571. CDER SBIA is making available this accompanying webinarwhich provides a description of the latest updates to the FDA’s Forms 356h and 1571 released in May 2018. These changes include identifying if the product is a Commercial IND or Research IND, the identification of Combination Products, and the inclusion of the Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT).

This webinar offers a detailed live walk-through of the completed 356h and 1571 forms, with these fields, with mock-data.

Resources

• Webinar
• Slides (PDF - 1.2MB) 
• 356h & 1571 (MP3 - 8MB)
• FDA Forms
• FDA Blog on SNOMED CT

For questions concerning the webinar, please contact CDER SBIA at: (866) 405-5367 | (301) 796-6707