FDA to Require eCTD for NDAs and ANDAs Beginning May 5, 2017
The U.S. Food and Drug Administration (FDA) will require all New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) submissions to be in electronic common technical document (eCTD) format beginning May 5, 2017. eCTD will be required for Drug Master File (DMF) submissions beginning May 5, 2018.
FDA’s new eCTD requirements affect the following types of submissions:
- New NDAs, ANDAs, and DMFs
- Letters of Authorization
- Adverse Event Reporting
Transitioning to eCTD can be lengthy and complicated. Registrar Corp can help convert your submissions to eCTD quickly and easily.