Industry News

FDA Requests Court of Appeals to Stay Order
October 22, 2013

In an emergency motion filed on October 18th, the Food and Drug Administration (FDA) requested the U.S. Court of Appeals for the Ninth Circuit to stay a June order mandated by a District Court Judge.  In the motion, the FDA claims that due to the government shutdown, the agency will not have enough time to receive feedback from industry members, thus making the mandated November 30th deadline impossible to meet.  The FDA requests additional time beyond the allowed 16 day government extension to assure the proposed regulation is consistent with the public interest.

On September 16th, the FDA filed the appeal at the U.S. Court of Appeals for the Ninth Circuit, contesting the June 21st order issued by a District Court Judge in California.  The order mandated the FDA to comply with the following: publish all proposed FSMA mandated regulations by November 30, 2013, close all comment periods by March 31, 2014, and publish all final regulations by June 30, 2015. 

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