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UPDATED INFORMATION (as of September 24, 2020):

The meeting time has changed to 10 a.m. to 4 p.m. EST for the October 9, 2020 Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee.

The Agenda has been changed and reads as follows:

The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. The committees will discuss the efficacy, safety, and benefit-risk profile of new drug application (NDA) 213378, olanzapine/samidorphan oral tablets, submitted by Alkermes, Inc., for the proposed indications of schizophrenia and bipolar I disorder.

Additionally, the meeting materials information has been changed and reads as follows:

FDA intends to make the meeting’s background material and pre-recorded presentations available to the public no later than 2 business days before the meeting. The pre-recorded presentations will be viewed by the committee prior to the meeting and will not be replayed on meeting day. If FDA is unable to post the background material and/or pre-recorded presentations on its website prior to the meeting, the background material and/or pre-recorded presentations will be made publicly available on FDA’s website at the time of the advisory committee meeting. The meeting will include brief summaries of the pre-recorded presentations. Background material and the link to the online teleconference meeting room will be available at Advisory Committee Calendar. Scroll down to the appropriate advisory committee meeting link.

All other information remains the same.

 

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ORIGINAL INFORMATION

Agenda

The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. The committees will discuss the efficacy, safety, and benefit-risk profile of new drug application (NDA) 213378, olanzapine and samidorphan oral tablets, submitted by Alkermes, Inc., for the proposed indications of schizophrenia and bipolar disorder.

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 on FDA’s website at the time of the advisory committee meeting.  Background material and the link to the online teleconference meeting room will be available at: https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. 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-1767. The docket will close on October 8, 2020.  Submit either electronic or written comments on this public meeting by October 8, 2020.  Please note that late, untimely filed comments will not be considered.  Electronic comments must be submitted on or before October 8, 2020.  The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of October 8, 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 September 25, 2020 will be provided to the committees.  Comments received after that date but by October 8, 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: www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to 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 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-1767 for “Joint Meeting of the Psychopharmacologic Drugs Advisory Committee (PDAC) and the Drug Safety and Risk Management (DSaRM) 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 www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.

• 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 www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to 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 this 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 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.

Oral presentations from the public will be scheduled on October 9, 2020 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 September 16, 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 September 17, 2020.

Webcast Information

CDER plans to provide a free of charge, live webcast of the October 9, 2020 Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. 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: https://www.fda.gov/advisory-committees/human-drug-advisory-committees/psychopharmacologic-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

• CDR LaToya Bonner, PharmD
  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:  [email protected]

• 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.

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