FDA public hearings
Executive Summary
Agency proposing amendment to regulations on formal evidentiary public hearings to extend from 30 to 60 days the period for filing exceptions to the initial decision of the administrative law judge and replies to exceptions. Proposed rule specifies that extensions to the 60-day periods will only be granted in "extraordinary circumstances," including "death or hospitalization of counsel or extended unavailability of a party's scientific advisors." Comments on the proposed rule, published in the Feb. 1 Federal Register, are being accepted until April 1.