WASHINGTON – The Consumer Healthcare Products Association (CHPA) released the below statement following the U.S. Food and Drug Administration’s (FDA) announcement that it will postpone its previously scheduled April 12 Nonprescription Drugs Advisory Committee (NDAC) meeting to reconsider the efficacy of oral phenylephrine (PE):
“CHPA is pleased to see today’s news that FDA has postponed the recently announced Advisory Committee meeting,” said senior vice president of Regulatory & Scientific Affairs, Barbara Kochanowski. “Given the critical importance of this meeting on behalf of the millions of consumers who rely on this ingredient, a reasonable amount of time is needed for regulated Industry to provide a complete picture of the previously reviewed data demonstrating phenylephrine as generally recognized as safe and effective (GRASE). It is imperative that the advisory committee has access to all the data in order to provide FDA the best possible advice as the Agency undertakes this evaluation.”
Comments are closed.