Description
This document provides guidance to industry sponsors, applicants, and petitioners (referred to collectively as sponsors) who develop, prepare, or submit briefing materials that will be given to advisory committee members as background information before an open FDA advisory committee meeting. This guidance will help sponsors develop, organize, and submit advisory committee briefing materials for public release and should help minimize the time and resources spent in preparing these materials for public availability. The guidance also describes the process FDA intends to follow when we make briefing materials available to the public. In addition, the Appendices provide recommended timelines for preparing and submitting briefing materials to us.
Key Topics
Terms and concepts identified from this document
Scope & Applicability
Stakeholders
6Contact point for questions regarding the guidance document.
Entity receiving written comments on the draft guidance
Point of contact for briefing materials
Entity responsible for submitting applications under section 524B
Federal employee responsible for administrative management of an advisory committee.
Individuals receiving briefing materials for review
Regulatory Context
Regulatory Activities
10The venue where expert advice is provided to the FDA.
Submission process applicable to optical imaging drugs.
Submission process applicable to optical imaging drugs.
Topic commonly discussed at advisory committee meetings for medical devices.
Topic commonly discussed at advisory committee meetings for medical devices.
Rule does not apply to products marketed under an NDA
Pending application discussed at advisory committee meetings.
Marketing submission type requiring QMS information; Type of marketing submission requiring QMS information
Premarket notification submission type
The venue where expert advice is provided to FDA; Proceedings involving review of product approval or safety; A meeting where experts review the safety and efficacy of a product.
Document Types
4Information posted on the FDA website prior to an advisory committee meeting.
Prescribing information that should reflect benefits and risks during pregnancy.
Materials submitted by sponsors for advisory committee meetings
Materials prepared by the agency for committee members
Attributes
2Information that the sponsor believes should not be public
Materials that do not contain redacted information
Technical Details
Processes
1Typically exempt from disclosure under FOIA.
Standards & References
External Standards
2Federal Advisory Committee Act disclosure requirements
Freedom of Information Act exemptions for disclosure
Related CFR Sections (11)
- 21CFR14.27§ 14.27 Determination to close portions of advisory committee meetings.
(a) No committee meeting may be entirely closed. A portion of a meeting may be closed only in accordance with a written determination by the Commissioner under this section.Read full regulation →
- 21CFR20.61§ 20.61 Trade secrets and commercial or financial information which is privileged or confidential.
(a) A trade secret may consist of any commercially valuable plan, formula, process, or device that is used for the making, preparing, compounding, or processing of trade commodities and that can be said to be the end product of either innovation or substantial effort. There must be a direct relationRead full regulation →
- 21CFR20.63§ 20.63 Personnel, medical, and similar files, disclosure of which constitutes a clearly unwarranted invasion of personal privacy.
(a) The names or other information which would identify patients or research subjects in any medical or similar report, test, study, or other research project shall be deleted before the record is made available for public disclosure.Read full regulation →
- 21CFR171.1§ 171.1 Petitions.
(a) Petitions to be filed with the Commissioner under the provisions of section 409(b) of the Federal Food, Drug, and Cosmetic Act (the act) shall be submitted in triplicate (quadruplicate, if intended uses include use in meat, meat food product, or poultry product). If any part of the material submRead full regulation →
- 21CFR314.430§ 314.430 Availability for public disclosure of data and information in an application or abbreviated application.
(a) The Food and Drug Administration will determine the public availability of any part of an application or abbreviated application under this section and part 20 of this chapter . For purposes of this section, the application or abbreviated application includes all data and information submitted wRead full regulation →
- 21CFR514.12§ 514.12 Confidentiality of data and information in an investigational new animal drug notice.
(a) The existence of an INAD notice will not be disclosed by the Food and Drug Administration unless it has previously been publicly disclosed or acknowledged.Read full regulation →
- 21CFR601.51§ 601.51 Confidentiality of data and information in applications for biologics licenses.
(a) For purposes of this section the biological product file includes all data and information submitted with or incorporated by reference in any application for a biologics license, IND's incorporated into any such application, master files, and other related submissions. The availability for publiRead full regulation →
- 21CFR860.5§ 860.5 Confidentiality and use of data and information submitted in connection with classification and reclassification.
(a) This section governs the availability for public disclosure and the use by the Commissioner of data and information submitted to classification panels or to the Commissioner in connection with the classification or reclassification of devices under this part.Read full regulation →
- 21CFR14.29§ 14.29 Conduct of a hearing before an advisory committee.
(a) For each meeting, the open portion for public participation, which constitutes a public hearing under § 14.25(a) , will be at least 1 hour, unless public participation does not last that long, and may last for whatever longer time the committee Chairperson determines will facilitate the work of Read full regulation →
- 21CFR14.35§ 14.35 Written submissions to an advisory committee.
(a) Ten copies of written submissions to a committee are to be sent to the Designated Federal Officer unless an applicable Federal Register notice or other regulations in this chapter specify otherwise. Submissions are subject to the provisions of § 10.20 , except that it is not necessary to send coRead full regulation →
- 21CFR10.20§ 10.20 Submission of documents to Dockets Management Staff; computation of time; availability for public disclosure.
(a) A submission to the Dockets Management Staff of a petition, comment, objection, notice, compilation of information, or any other document is to be filed in four copies except as otherwise specifically provided in a relevant Federal Register notice or in another section of this chapter. The DockeRead full regulation →
See Also (8)
- Guidance For The Content Of Premarket Notifications For Esophageal And Tracheal Prostheses - Guidance For Industry (Status: Final)
- Master Files Part III - Guidance on Scientific and Technical Information (Status: Final)
- Prospective Manufacturers of Barrier Devices Used During Oral Sex for STD Protection (Status: Final)
- CVM GFI #187B Heritable Intentional Genomic Alterations in Animals: The Approval Process (Status: Final)
- 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review: Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations (Status: Final)
- Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection: Guidance for Industry (Status: Final)
- Guidance for Industry: New Dietary Ingredient Notification Procedures and Timeframes - Dietary Supplements (Status: Final)
- Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act (Status: Final)