FDA Clarifies Postmarket Filings To Meet ICH Standards

The FDA wants to see both efficacy and effectiveness data in future postmarket filings to better conform to International Conference on Harmonization standards.

A final guidance bemoaning the lack of standardization between the U.S., Europe and Japan in postmarket submissions makes a point of distinguishing clinical efficacy data from medical practice efficacy data. The document pushes for both when companies submit periodic benefit/risk evaluation reports.

This change is intended to unify regulatory standards among those regions, some of which may interpret data efficacy or effectiveness as being exclusively clinical or medical.

The final guidance largely follows a 2012 draft document, providing a few additional points for drugmakers to consider when filing the reports.

For example, the FDA explains that fixed-dose combination products can have a cutoff date for data based on either the earliest marketing approval of one of the product’s components or the combination itself.

The agency released the final guidance in conjunction with a Q&A on periodic benefit/risk reports. The document functions as an FAQ for various scenarios companies may encounter, such as running deadlines among various regulatory agencies.

In that case, the document advises drugmakers to submit data as updates to prior filings as it becomes available to fulfill the deadline of other agencies.

Read the final guidance here: www.fdanews.com/07-18-16-FDAGuidancePBRER.pdf.

Read the Q&A guidance here: www.fdanews.com/07-18-16-FDAQAGuidancePBRER.pdf. — José Vasquez

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