Refuse to File victims will get a hearing

WASHINGTON - The FDA said it will change its procedures so applicants that have received a Refusal to File (RTF) notice will be allowed to attend the meeting at which the Center for Drug Evaluation and Research's RTF review committee evaluates the decision.

The new policy, which will be implemented on a trial basis, "may enhance understanding of and participation in the RTF review committee process," the agency said in a Federal Register notice last week. ...