The US Food and Drug Administration (FDA) wants your valentines, or at least a letter saying that you love them so much, because they accurately listed your products in the “Approved Drug Products with therapeutic Equivalence Evaluations,” better known as the Orange Book.
As part of the FDA Reauthorization Act of 2017 (FDARA), there is a requirement of a one-time marketing status report, which is just a letter to the FDA indicating that the products listed in the Orange Book are still on the market or not. This report is due six months after the FDARA was passed, which is February 14, 2018.
To make it a little less burdensome, FDA is permitting companies to submit this statement for all of their products that have the same Application Type (New Drug Applications, versus Abbreviated New Drug Applications) in a single submission as a Grouped Submission, if you use the version 3.3 DTD specification for the FDA eCTD Module 1. Note however, that if you use version 3.3, all future submissions for those products must also use version 3.3. You may use individual submission sequences for each product, but that may be a larger burden.
The report is just the cover letter, stating either that all products listed in the Orange Book are still on the market, or all except those listed in a table – either withdrawn from the market, or never having been marketed.
In ARIM version 3 and newer, locate one of your products in the Publisher module, and create a new submission to the United States.
- Make sure you specify version 3.3 for the Regional DTD
- Set the description to “MARKETING STATUS REPORT / ONE-TIME UPDATE”
- Set the Submission Type and Sub-Type to Product Correspondence / Correspondence
- Add the 356h form and the cover letter containing the report
- Press the publish button on the Submissions blade, and add other applications as a bundled submission. ARIM requires a 356h form for each product, but you can specify the same file for each.
- Press the publish button on the Publish blade
We have also provided a shell document in Microsoft Word format for the MARKET STATUS REPORT. It’s designed for simplest use with our template package ARID – which you can download for a 30-day trial – but should be usable with just Microsoft Word, so long as you update the applicant name using File > Properties.
You can download the shell dcument here: 0000-cover-MSR.docx.
Please contact ACUTA for questions about complying with this FDA requirement, or to have us assist you in creating the submission.