date:
November 2 – 3, 2022
time:

9:00 AM – 3:30 PM ET


center location
CDR 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

Meeting presentations will be heard, viewed, captioned and recorded via an online teleconferencing platform. The meeting will focus on two topics related to the Office of Pharmaceutical Quality’s mission to promote access to quality medicines for the American public. On November 2, 2022, the committee will discuss the Center for Drug Evaluation and Research (CDER) Quality Management Maturity (QMM) program. QMM is the state achieved when pharmaceutical manufacturers have consistent, reliable and robust business processes to achieve quality objectives and promote continuous improvement. CDER proposed the development of an evaluation system that would help encourage pharmaceutical manufacturers to adopt more mature quality management practices in their facilities. The committee will consider the impact of the QMM program on the pharmaceutical industry, drug shortages, and supply chain resilience. FDA will seek input from experts from academia and industry to determine whether CDER supports the development of a QMM program to encourage investment in mature quality management practices.

On November 3, 2022, as part of CDER’s ongoing effort to provide key updates on the modernization of quality assessment, the Committee will discuss the next steps for Knowledge-Assisted Assessment and Structured Application (KASA). The concept of KASA was conceptualized in 2016 and was discussed at the September 20, 2018 meeting of the Pharmaceutical Sciences and Clinical Pharmacology Advisory Committee as an IT system to modernize FDA’s evaluation. Through the development, testing and implementation of various KASA prototypes, the KASA system has been refined over a period of several years. FDA will seek input on the vision and plans to expand KASA over the next 5 years to include drug substances, all generic dosage forms, new drug and biologics applications, and post-approval changes. Further, FDA will seek input on the need to advance digitization in KASA, including data standardization and mobilization of data from cloud-based servers.

Meeting material

FDA intends to make background materials and a link to the live webcast available to the public two (2) business days prior to the meeting in the Event Materials section of this web page. If FDA is unable to post background material on its website prior to the meeting, background material will be made publicly available on FDA’s website during the Advisory Committee meeting. The meeting will include slide presentations with an audio component that will make the presentation of the materials similar to an in-person Advisory Committee meeting.

Public participation information

Interested persons may present data, information or opinions orally or in writing on issues pending before the Committee.

FDA is establishing a docket for public comment at this meeting. The docket number is FDA-2022-N-1777. The docket will close on November 1, 2022. Submit electronic or written comments to this public meeting by November 1, 2022. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before November 1, 2022. The https://www.regulations.gov electronic filing system will accept comments until November 1, 2022 at 11:59 p.m. Eastern Time. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acknowledgment receipt is on or before that date.

Comments received by October 19, 2022 will be provided to the Committee. Comments received after that date but until November 1, 2022 will be considered by the FDA. If the meeting is canceled, FDA will continue to evaluate any relevant applications or information, and consider any comments submitted to the docket, as appropriate. You can submit comments as follows:

Electronic Submissions

Submit electronic comments in the following ways:

  • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions to submit a comment. Comments submitted electronically, including attachments, will be posted in the unchanged docket at https://www.regulations.gov . Because your comments will be made public, your comments will not include any confidential information that you or a third party would not want posted, such as medical information, your or someone 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 comment, that information will be posted at https://www.regulations.gov.
  • If you wish to submit a comment containing confidential information that you do not wish to make publicly available, submit the comment as a written/paper submission and in detail (see “Written/Paper Submissions” and “Instructions”).

Written/Paper Submissions

Submit a written/paper submission as follows:

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

Instructions: All submissions received must include a docket number. FDA-2022-N-1777 “For the Pharmacology and Clinical Pharmacology Advisory Committee; Notice of Meeting; Establishment of Public Docket; Request for Comments.” Comments received, timely filed comments will be placed in the docket and except those submitted as “confidential submissions” https://www.regulations.gov can be viewed by the public at or between 9 a.m. and 4 p.m. Dockets Management staff, Monday through Friday, 240-402-7500.

  • Confidential Submissions– To submit a comment containing confidential information that you do not wish to make publicly available, submit your comments only as a written/paper submission. You must submit a total of two copies. One copy will contain the information you claim is confidential with a heading or cover note stating “This document contains confidential information.” FDA will review this copy in consideration of the comments, including the claimed confidential information. A second copy, in which the claimed confidential information will be redacted/blacked out, will be available for public viewing and posted at https://www.regulations.gov. Submit both copies to Dockets Management staff. If you do not wish to make your name and contact information publicly available, you may provide this information on a cover page rather than in the body of your comment, and you must identify the information as “confidential.” Any information marked “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure laws. For more information about FDA posting comments in 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 electronic and written/paper comments received, visit https://www.regulations.gov and enter the docket number found in parentheses in the title of this document, in the “Search.” box and follow the prompts. /or visit Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.

Public oral presentations will be scheduled on November 2, 2022 from 1 pm to 2 pm Eastern Time. Oral presentations from the public will be scheduled on November 3, 2022 between approximately 1:10 pm and 2:10 pm Eastern Time. Persons wishing to make formal oral presentations should notify the contact person and submit a brief description 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. Their presentation on or before October 11, 2022.

The time allotted for each presentation may be limited. If the number of registrants requesting to speak exceeds what can reasonably be accommodated in the scheduled open public hearing session, FDA may conduct a lottery to determine speakers for the scheduled open public hearing session. The contact person will notify interested individuals of their request to speak by October 12, 2022.

Webcast Information

CDER plans to provide a free live webcast of the November 2-3, 2022 Pharmacology and Clinical Pharmacology 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. Additional information regarding the webcast, including the web address for the webcast, will be made available two (2) business days prior to the meeting in the event content section of this web page.

CDER plans to post the archived webcasts after the meeting, however, in the event that the broadcast is not successful, the archived webcasts will not be available.

Contact information

  • FDA Advisory Committee Information Line
    1-800-741-8138
    (301-443-0572 in the Washington DC area)
    Please call the information line for updated information on this meeting.
  • For press inquiries, please contact the Office of Media Affairs at [email protected] or 301-796-4540.

Notices in the Federal Register about last-minute amendments affecting previously announced advisory committee meetings may not 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 official (see contact information) to learn about potential amendments before coming to the meeting.

Those attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes public attendance at its advisory committee meetings and will make every effort to accommodate individuals with disabilities. If you need an accommodation because of a disability, please contact the committee’s designated federal official at least 7 days in advance (see contact information).

Answers to commonly asked questions, including information about special accommodations due to disabilities, can be accessed here: Common Questions and Answers about FDA Advisory Committee Meetings.

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

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