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FDA Announces Public Advisory Committee Meeting for Discussion of New Drug Application for Avacopan

ACTION:  Arthritis Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
AGENCY:  Food and Drug Administration, HHS.
A Notice by the Food and Drug Administration on 03/26/2021

SUMMARY:  The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Arthritis Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.

Agenda:  The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. The committee will discuss new drug application (NDA) 214487, for avacopan oral capsules, submitted by ChemoCentryx, Inc., for the treatment of anti-neutrophil cytoplasmic antibody-associated vasculitis.

DATES:  The meeting will take place virtually on May 6, 2021, from 10 a.m. to 4:15 p.m. Eastern Time.



ADDRESSES:  Please note that due to the impact of this COVID-19 pandemic, all meeting participants will be joining this advisory committee meeting via an online teleconferencing platform. Answers to commonly asked questions about FDA advisory committee meetings may be accessed at:

FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2021-N-0273. The docket will close May 5, 2021. Submit either electronic or written comments on this public meeting by May 5, 2021. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before May 5, 2021. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of May 5, 2021. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.

Comments received on or before April 22, 2021, will be provided to the committee. Comments received after that date will be taken into consideration by FDA. In the event that the meeting is cancelled, FDA will continue to evaluate any relevant applications or information, and consider any comments submitted to the docket, as appropriate.

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).
Dated: March 22, 2021.

Lauren K. Roth, Acting Principal Associate Commissioner for Policy.
Federal Register:  The Daily Journal of the US Government