Zdrowie i gospodarka · 08/05/2012

Gastrointestinal Drugs Advisory Committee; Cancellation

The meeting of the Gastrointestinal Drugs Advisory Committee scheduled for May 31, 2012, is canceled. This meeting was announced in the Federal Register of March 23, 2012 (77 FR 17078). The meeting is being canceled because the Agency no longer needs to discuss the issues that were originally under consideration in the review of the application. The sponsor of the new drug application (NDA) submitted new information which negated the necessity for the planned meeting. The Agency intends to continue evaluating NDA 200-436 and, as needed, may schedule an Advisory Committee meeting in the future.