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Advisory Committee Meeting

Event Title
UPDATED TIME AND PUBLIC PARTICIPATION INFORMATION: July 15, 2020 Meeting of the Cardiovascular and Renal Drugs Advisory Committee Meeting Announcement
July 15, 2020


Date:
July 15, 2020
Time:
9:00 AM - 5:00 PM ET

UPDATED INFORMATION (as of 7/7/2020):

The meeting time has changed to 9 a.m. to 5 p.m. for the July 15, 2020 meeting of the Cardiovascular and Renal Drugs Advisory Committee.

Additionally, the public participation information has been changed. Oral presentations from the public will be scheduled between approximately 1:30 p.m. and 2:30 p.m. on July 15, 2020. The deadline for making formal oral presentation requests has been changed from Wednesday, July 8, 2020 to Friday, July 10, 2020. Interested persons will be notified regarding their request to speak by Monday, July 13, 2020. The deadline for submitting electronic or written comments to be provided to the committee has been changed from Friday, July 10, 2020 to Monday, July 13, 2020.

All other information remains the same.

ORIGINAL INFORMATION:

Center Date Time Location
CDER July 15, 2020 8:00 a.m. to 5:00 p.m.
 
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.

Agenda

The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. On July 15, 2020, the committee will be asked to discuss new drug application (NDA) 22231, terlipressin, lyophilized powder for solution for injection,submitted by Mallinckrodt Pharmaceuticals, for the proposed indication of treatment of hepatorenal syndrome Type 1.

Meeting Materials

FDA intends to make background material available to the public no later than two (2) business days before the meeting.  If FDA is unable to post the background material on its web site prior to the meeting, the background material will be made publicly available at the time of the advisory committee meeting, Background material is available at: 2020 Meeting Materials, Cardiovascular and Renal Drugs Advisory Committee. Scroll down to the appropriate advisory committee meeting link. The meeting will include slide presentations with audio components to allow the presentation of materials in a manner that most closely resembles an in-person advisory committee meeting.

Public Participation Information

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-2020-N-1330.  The docket will close on July 14, 2020.  Submit either electronic or written comments on this public meeting by July 14, 2020.  Please note that late, untimely filed comments will not be considered.  Electronic comments must be submitted on or before July 14, 2020.  The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of July 14, 2020.  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 July 10, 2020 will be provided to the committee.  Comments received after that date but by July 14, 2020 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. You may submit comments as follows: 

Electronic Submissions
Submit electronic comments in the following way:

  • Federal eRulemaking Portal:  https://www.regulations.gov.  Follow the instructions for submitting comments.  Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged.  Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process.  Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.
  • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

Written/Paper Submissions
Submit written/paper submissions as follows:

  • Mail/Hand delivery/Courier (for written/paper submissions):  Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
  • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

Instructions:  All submissions received must include the Docket No. FDA-2020-N-1330 for “Cardiovascular and Renal Drugs Advisory Committee Meeting; Notice of Meeting; Establishment of a Public Docket; Request for Comments.”  Received comments, those filed in a timely manner, will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. Please call 240-402-7500 ahead of the meeting time to verify access.

  • Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission.  You should submit two copies total.  One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.”  FDA will review this copy, including the claimed confidential information, in its consideration of comments.  The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov.  Submit both copies to the Dockets Management Staff.  If you do not wish your name and contact information be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify the information as “confidential.”  Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law.  For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

Docket:  For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.

Oral presentations from the public will be scheduled between approximately 1:00 p.m. to 2:00 p.m.  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 July 8, 2020.

Time allotted for each presentation may be limited.  If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by July 9, 2020.

Webcast Information

CDER plans to provide a free of charge, live webcast of the July 15, 2020 Cardiovascular and Renal Drugs Advisory Committee meeting. If there are instances where the webcast transmission is not successful, staff will work to re-establish the transmission as soon as possible. Further information regarding the webcast, including the web address for the webcast, will be made available at least 2 days in advance of the meeting at the following website: 2020 Meeting Materials, Cardiovascular and Renal Drugs Advisory Committee.

CDER plans to post archived webcasts after the meeting, however, in cases where transmission was not successful, archived webcasts will not be available.

Contact Information

  • Joyce Yu

Center for Drug Evaluation and Research
Food and Drug Administration
10903 New Hampshire Avenue
WO31-2417
Silver Spring, MD  20993-0002

Phone:  301-796-9001
FAX:  301-847-8533
Email:  CRDAC@fda.hhs.gov

  • FDA Advisory Committee Information Line

1-800-741-8138
(301-443-0572 in the Washington DC area)
Please call the Information Line for up-to-date information on this meeting.


A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency’s website or call the committee’s Designated Federal Officer (see Contact Information) to learn about possible modifications before coming to the meeting.

Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact the committee’s Designated Federal Officer (see Contact Information) at least 7 days in advance of the meeting.

Answers to commonly asked questions including information regarding special accommodations due to a disability may be accessed at: Common Questions and Answers about FDA Advisory Committee Meetings.

FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at Public Conduct During FDA Advisory Committee Meetings for procedures on public conduct during advisory committee meetings.

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app.2).


Event Materials

Title File Type/Size Source Organization
Committee Roster for the July 15, 2020 Meeting of the Cardiovascular and Renal Drugs Advisory Committee pdf (79.81 KB)
Webcast Information for the July 15, 2020 Meeting of the Cardiovascular and Renal Drugs Advisory Committee pdf (79.62 KB)
FDA Briefing Information for the July 15, 2020 Meeting of the Cardiovascular and Renal Drugs Advisory Committee pdf (1.40 MB)
Errata to the FDA Briefing Information for the July 15, 2020 Meeting of the Cardiovascular and Renal Drugs Advisory Committee pdf (90.66 KB)
Mallinckrodt Briefing Information for the July 15, 2020 Meeting of the Cardiovascular and Renal Drugs Advisory Committee pdf (3.44 MB)
Final Agenda for the July 15, 2020 Meeting of the Cardiovascular and Renal Drugs Advisory Committee (CRDAC) pdf (19.27 KB)
Final Questions for the July 15, 2020 Meeting of the Cardiovascular and Renal Drugs Advisory Committee (CRDAC) pdf (64.29 KB)
Final Meeting Roster for the July 15, 2020 Meeting of the Cardiovascular and Renal Drugs Advisory Committee (CRDAC) pdf (78.70 KB)
FDA Slides for the July 15, 2020 Meeting of the Cardiovascular and Renal Drugs Advisory Committee (CRDAC) pdf (564.44 KB)
Mallinckrodt Slides for the July 15, 2020 Meeting of the Cardiovascular and Renal Drugs Advisory Committee (CRDAC) pdf (1.97 MB)
Minutes for the July 15, 2020 Meeting of the Cardiovascular and Renal Drugs Advisory Committee (CRDAC) pdf (151.73 KB)
Transcript for the July 15, 2020 Meeting of the Cardiovascular and Renal Drugs Advisory Committee pdf (1.01 MB)

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