Stipulation of Dismissal in Winston Laboratories Small Business User Fee Waiver Case

By Michelle L. Butler

This week, the parties in the Winston Laboratories case filed a Stipulation of Dismissal with Prejudice Pursuant to Fed. R. Civ. P. 41(a). This case involved FDA’s interpretation of the term “affiliate” in its decision to deny Winston a small business waiver of the PDUFA fee for a new drug application. Given the Court’s prior decision denying the Government’s Motion to Dismiss, it is likely that the parties settled the case on terms favorable to Winston. We do not yet know how FDA will deal with similar small business waiver determinations going forward, but we will provide updates as information becomes available.