One-Time Report on Marketing Status Required by FDARA – Are You Ready?

After the glow of the holiday season, and after the big bowl games and national football championship, you better get the team prepared to file your one-time report of the marketing status of every one of your NDA and ANDA products.

FDARA requires every firm to submit the one time written report telling FDA if:

  1. the NDA or ANDA holder’s drug(s) in the active section of the Orange Book are available for sale; or
  2. one or more of the NDA or ANDA holder’s drugs in the active section of the Orange Book have been withdrawn from sale or have never been available for sale.

We hope you recognize that the deadline for submission of the information is Wednesday, February 18, 2018.  So happy New Year and get writing!

The FDA notice (here) provides detailed information on the information that is required to be submitted and describes how to submit the reports.  The notice does not outline the penalties for not submitting the report in a timely manner, but, as well all realize, one never likes to be on the end of that stick.