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PREA – Pediatric Plan Timing Changed by PDUFA V

The Food and Drug Administration Safety and Innovation Act (FDASIA; also known as PDUFA V), signed into law on July 9, 2012, contains amendments to the Pediatric Research Equity Act (PREA) that specifically detail the timing of the submission of a Pediatric Study Plan (PSP). In order to direct greater adherence to the PREA requirements before a sponsor submits an NDA, FDASIA states that the PSP must be submitted within 60 days of an End-of-Phase 2 meeting, or at a time agreed upon with the FDA. Although this timing for PSP submission is not entirely new, since FDASIA was passed there is a greater emphasis on enforcing the requirement. In instructions received from FDA review divisions, Sponsors are given further clarification that for drug development programs/INDs that had an End-of-Phase 2 meeting during or before 2012, or programs that do not intend to hold an End-of-Phase 2 meeting [such as programs that do not require clinical studies ie, some 505(b)(2)s], FDA review divisions further clarify that submission of a PSP depends on the date that the NDA is filed. If filed before 5 January 2014, these programs are “grandfathered” in that they may submit the PSP at the time of NDA filing or 210 days before NDA filing. Submission of the plan between these dates is not specifically addressed but is likely to be acceptable as the intent of this requirement is to encourage earlier submission of PSPs.

If NDA filing will occur on or after 5 January 2014, the PSP must be submitted no later than 210 days prior to NDA submission. Sponsors are being directed by FDA review divisions to a new draft Guidance for Industry (issued July 2013) that describes expanded content for PSPs that will be the subject of a future blog.

Dates to keep in mind:

NDA Filing Date PSP Due
January 5, 2014 6/9/2013
February 1, 2014 7/6/2013
March 1, 2014 8/3/2013
April 1, 2014 9/3/2013
May 1, 2014 10/3/2013