U.S. FDA Drug Master File Requirements
U.S. FDA CITATION: 21 C.F.R. Section 314.420
Drug companies can submit a Drug Master File (DMF) to the U.S. Food and Drug Administration (FDA) to provide confidential information about facilities, processes, or articles. The DMF holder can then authorize others to use the information in support of a submission to FDA without disclosing the information to anyone other than FDA.
FDA requires all DMF submissions to be in electronic common technical document (eCTD) format beginning May 5, 2018.
Registrar Corp assists with eCTD requirements. Our Regulatory Specialists will:
- File a new DMF with U.S. FDA in eCTD
- Update or Amend an existing DMF with U.S. FDA
- Convert existing DMFs to eCTD
- Serve as your Agent for U.S. FDA Communications
- Reactivate inactive DMFs with U.S. FDA and convert them to eCTD
For assistance with FDA eCTD requirements, simply complete the form below.