As announced in May, the Food and Drug Administration (FDA) is holding an open session to discuss and make recommendations on the safety and efficacy of AR101, Aimmune’s Oral Immunotherapy Candidate that was submitted to the FDA for approval at the end of last year. You are invited to participate.
The meeting of the Center for Biologics Evaluation and Research’s (CBER) Allergenic Products Advisory Committee (APAC) will take place September 13, 2019 from 8:30AM-4:30PM.
Interested persons may present data, information or views on issues pending before the committee in writing on or before September 6, or via oral presentation scheduled between approximately 1:00PM-2:00PM during the meeting. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before August 29, 2019.
CBER will provide a live webcast of the Allergenic Products Advisory Committee meeting free of charge at this link: https://collaboration.fda.gov/apac091319/
For more information, see their announcement by clicking here.
US FDA Accepts BLA Filing of Aimmune Therapeutics’ AR101 for Peanut Allergy
