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 the availability of quality medicines to 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 drug manufacturers have consistent, reliable and robust business processes to meet quality objectives and promote continuous improvement. CDER proposed the development of a rating system that would help incentivize drug manufacturers to adopt more mature quality management practices in their facilities. The committee will consider the impact a QMM program would have on the pharmaceutical industry, drug shortages and supply chain sustainability. FDA will seek input to determine whether academic and industry experts support the development of a CDER QMM program to stimulate investment in mature quality management practices.

On November 3, 2022, as part of CDER’s ongoing effort to provide key updates on quality assessment modernization, the committee will discuss the next stages of Knowledge-Assisted Assessment and Structured Application (KASA). The concept of KASA was envisioned in 2016 and discussed at the Pharmaceutical Sciences and Clinical Pharmacology Advisory Committee meeting on September 20, 2018 as an IT system that modernizes FDA evaluation. Through the development, testing and deployment of various KASA prototypes, the KASA system was refined over many 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 biologic applications, and post-approval changes. In addition, FDA will seek input on the need to advance digitization at KASA, including data standardization and data mobilization from cloud-based servers.

Materials for the meeting

FDA intends to make the background material and link to the live webcast available to the public no later than two (2) business days prior to the meeting in the Event Materials section of this web page. If FDA is unable to post the background material on its website prior to the meeting, the background material will be publicly available on the FDA website during the advisory committee meeting. The meeting will include slide presentations with audio components to allow materials to be presented in a manner that most closely resembles an in-person advisory committee meeting.

Information on public participation

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

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

Comments received on or before October 19, 2022 will be provided to the committee. Comments received after that date, but by November 1, 2022, will be considered by the FDA. In the event that the meeting is canceled, FDA will continue to evaluate any applicable submissions or information and will consider any comments submitted to the registry, as appropriate. You can submit comments as follows:

Electronic submissions

Submit electronic comments as follows:

  • Federal Electronic Rulemaking 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 registry unchanged. Because your comment will be made public, it is your sole responsibility to ensure that your comment does not include any confidential information that you or a third party may not want published, 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 comments, that information will be posted to https://www.regulations.gov.
  • If you wish to submit a comment with confidential information that you do not wish to be publicly available, please submit the comment as a written/paper submission and in the manner described (see “Written/Paper Submissions” and “Instructions”) .

Written/paper materials

Submit written/paper comments as follows:

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

Instructions: All requests received must include a document number. FDA-2022-N-1777 for “Pharmaceutical Sciences and Clinical Pharmacology Advisory Committee”; Notice of meeting; Creation of a public register; Request for Comments.” Comments received, those submitted in a timely manner, will be placed in the registry and, except for those submitted as “Confidential Comments,” publicly viewable at https://www.regulations.gov or at the Department of records management between 9 am and 4 pm, Monday through Friday, 240-402-7500.

  • Confidential Statements – To submit a comment with confidential information that you do not wish to be publicly available, submit your comments as a written/paper submission only. You must send a total of two copies. One copy will include the information you claim to be confidential with a title or headnote that reads “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” FDA will review this copy, including the requested confidential information, in reviewing the comments. The second copy, in which the requested confidential information will be redacted/redacted, will be available for public viewing and posted at https://www.regulations.gov. Send both copies to the records management staff. If you do not wish your name and contact information to be made public, you may provide this information on the title page rather than in the body of your comments, 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 law. For more information on FDA’s publication of comments in public records, 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.

Registry: To access the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and enter the docket number found in parentheses in the title of this document into “Search” and follow the prompts and/or go to the Document Management Team, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.

Oral presentations from the public will be scheduled between 1:00 PM and 2:00 PM ET on November 2, 2022. Oral presentations from the public will also be scheduled between approximately 1:10 PM and 2:10 PM ET on November 3, 2022. Persons interested in formal oral presentations should notify the contact person and send a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of the proposed participants, and an indication of the approximate time required to prepare their submission on or before October 11, 2022.

The time allotted for each presentation may be limited. If the number of registrants wishing to speak is greater than can reasonably be accommodated during the scheduled open public hearing session, FDA may hold a lottery to determine the speakers for the scheduled open public hearing session hearing. The contact person will notify interested parties of their request to speak by October 12, 2022.

Webcast Information

CDER plans to provide a free live webcast of the Pharmaceutical Sciences and Clinical Pharmacology Advisory Committee meeting on November 2-3, 2022. If there are instances where the webcast transmission is not successful, staff will work to restore transmission as possible soonest. Additional information regarding the webcast, including the webcast web address, will be made available no later than two (2) business days prior to the meeting in the Event Materials section of this web page.

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

Contact information

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

A notice in the Federal Register of last-minute modifications that affect 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 commission’s designated federal official (see Contact Information) to learn about possible changes before coming to the meeting.

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

Answers to frequently asked questions, including information about special accommodations due to a disability, can be found at: Frequently Asked Questions and Answers About FDA Advisory Committee Meetings.

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

Notice of this meeting is given pursuant to the Federal Advisory Committee Act (5 USC App. 2).