FDA to Hold Public Meeting to Discuss Patient-Focused Drug Development for Autism

March 7, 2017

FDA Grants Breakthrough Therapy Status for Drug to Treat Autism

On Monday, March 6th, the FDA announced plans to hold a public meeting regarding the development of patient-focused drugs for autism.  In the notice published in the Federal Register, the FDA notes that its concentration on patient-focused drug development is part of its performance commitments made under the fifth authorization of the Prescription Drug User Fee Act (PDUFA V).

Meeting Details


Thursday, May 4, 2017


1 to 5 pm


FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD 20993


“To allow FDA to obtain patient perspectives on the impact of autism on daily life as well as patient views on treatment approaches for autism.”


People interested in attending the meeting are required to register for the event. Registration closes on April 24, 2017.  For additional information on registration, view FDA’s supplementary information.

In addition to the meeting, FDA is also announcing an opportunity for public comment on the topic.  The deadline to submit comments is July 5, 2017.  Electronic comments must be submitted on or before July 5th, and written paper submissions must be postmarked is on or before that date.

Additional details are available in FDA’s Federal Register notice.

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