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VRBPAC Meeting – Rebiotix Indication for Recurrent Clostridioides difficile Infection

September 22 @ 8:30 am - 5:00 pm EDT

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The Vaccines and Related Biological Products Advisory Committee (VRBPAC) will convene on 22 September 2022 to discuss the Biologics License Application # 125739 (BLA – 125739) from Rebiotix Inc. for a product, Rebyota (Fecal Microbiota, Live), with a requested indication to “reduce the recurrence of Clostridioides difficile infection (CDI) in adults following antibiotic treatment for recurrent Clostridioides difficile infection.”

FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting, any background material will be made publicly available at the time of the advisory committee meeting, and additional materials will be posted on FDA’s website after the meeting.

Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. FDA is establishing a docket for public comment on this meeting.

The Docket Number is FDA-2022-N-1608.

Details

Date:
September 22
Time:
8:30 am - 5:00 pm EDT
Event Categories:
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Website:
https://bit.ly/3R5RQUe
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Organizer

Center for Biologics Evaluation and Research (CBER), FDA