FDARA Marketing Status Reports Due

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Time is running out for an item that may require your regulatory compliance attention. The FDA reminded the public of a one-time requirement for all companies to submit a marketing status report. By law, FDARA marketing status reports are due on or before February 14, 2018. The FDA Reauthorization Act of 2017 (FDARA) mandated this requirement.

The FDARA requires every firm to submit this report telling FDA if:

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  • one or more of the NDA or ANDA holder’s drugs in the active section of the Orange Book have been withdrawn from sale or have never been available for sale.

This submission should be filed electronically to your eCTD. You should submit these one-time reports to FDA by letter to each applicable NDA or ANDA file. The FDA suggests grouping these submissions to your eCTD via the ESG, with the intent to eliminate the need to submit multiple, identical submissions to different applications.

When you submit, make sure you prominently identify the submission as “MARKETING STATUS REPORT / ONE-TIME UPDATE” on your correspondence.

More details are posted on FDA’s website.

Need some help submitting these reports? Contact Synchrogenix today regarding your eCTD publishing, Regulatory Strategy, Regulatory Affairs, and/or Regulatory and Medical Writing needs.


Author: Synchrogenix

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