Mar 01

Submitting a “Request for Proprietary Name Review” in eCTD format to the FDA

By Christine Straccini, B.Sc., C.C.R.P., Regulatory Associate at Cato Research

Per the April 2016 Guidance for Industry entitled, “Contents of a Complete Submission for the Evaluation of Proprietary Names”, applicants must submit proposed proprietary names to the FDA for review as part of New Drug Applications (NDAs), Abbreviated NDAs (ANDAs) and Biologics License Applications (BLAs).  If such an application is not yet available, it is acceptable to submit the request to an active Investigational New Drug (IND) application provided the product has completed Phase 2 trials.

If submitting electronically in eCTD format, the request is placed in the following sections depending on the US regional DTD version being used:

  • US regional DTD v3.3
    • A “Request for Proprietary Name Review” is placed in “Section 1.18 Proprietary Names”
  • US regional DTD v2.01
    • A “Request for Proprietary Name Review” is placed in “Section 1.12.4 Request for Comments and Advice on an IND”

In both cases, the eCTD leaf title of the document should be clear, concise, and indicative of the document’s content (e.g. “REQUEST FOR PROPRIETARY NAME REVIEW”, “AMENDMENT TO REQUEST FOR PROPRIETARY NAME REVIEW”, or “REQUEST FOR RECONSIDERATION OF PROPRIETARY NAME”).  Moreover, the eCTD location of the request should be included and hyperlinked in the cover letter so the information can be quickly and easily accessed by reviewers.

The FDA will evaluate both safety and promotional aspects of the product’s proposed proprietary name; a tentative acceptance or non-acceptance about the name will be communicated to the applicant within 180 days during the IND phase and 90 days with an NDA or BLA.