Rules and Regulations. Notice of availability

Agency: Food and Drug Administration, HHS
Action: Notice of availability
Citation: FR Doc. 2024-31305 · Docket No. FDA-2024-D-4490

Summary

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Combined FDA and Sponsor Oncologic Drugs Advisory Committee (ODAC) Briefing Document.” This draft guidance provides recommendations to sponsors regarding use and development of a combined version of the ODAC briefing document, as part of the Oncology Center of Excellence's (OCE) Project Point/Counterpoint initiative. This single document includes information that customarily would be contained in separate briefing documents prepared individually by the Sponsor and FDA. Project Point/Counterpoint is an option for advisory committee meetings for oncology products. Sponsors in non-oncology therapeutic areas who want to discuss whether a combined advisory committee briefing document may be appropriate for their applications should contact the relevant review division. This briefing document format may provide efficiencies by allowing Sponsors and FDA to choose to use a single document that provides the views of the Sponsor and FDA on key issues.

Dates

Submit either electronic or written comments on the draft guidance by February 28, 2025 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.

Supplementary Information

I. Background FDA is announcing the availability of a draft guidance for industry entitled “Combined FDA and Sponsor Oncologic Drugs Advisory Committee (ODAC) Briefing Document.” This guidance provides recommendations to sponsors regarding use and development of a combined version of the briefing document for matters before the ODAC, as part of the OCE Project Point/Counterpoint initiative. This single briefing document includes information that customarily would be contained in separate briefing documents prepared individually by the Sponsor and FDA. Project Point/Counterpoint is an option for advisory committee meetings for oncology products. Sponsors in non-oncology therapeutic areas who want to discuss whether a combined advisory committee briefing document may be appropriate for their applications should contact the relevant review division. Sponsors and FDA customarily prepare their own separate ODAC briefing documents. This can lead to repetition of information ( i.e., trial design, endpoints, eligibility criteria, etc.) and increases the number of documents that ODAC committee members need to review. Additionally, ODAC committee members may need to go back and forth from each briefing document to consider the Sponsor's and FDA's position on each issue. Project Point/Counterpoint may provide efficiencies by allowing Sponsors and FDA to choose to use a single document that provides the views of the Sponsor and FDA on key issues. The combined briefing document was first piloted for use at an ODAC meeting in December 2019. This format decreases the number of documents ODAC members must review by providing the applicant's and FDA's positions in one document. It serves as a stand-alone document containing the background information and an objective description of the data for the clinical trial or topic under discussion at ODAC, followed by the positions of the Sponsor and FDA. This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on “Combined FDA and Sponsor Oncologic Drugs Advisory Committee (ODAC) Briefing Document.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. II. Paperwork Reduction Act of 1995 FDA tentatively concludes that this draft guidance contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required. III. Electronic Access Persons with access to the internet may obtain the draft guidance at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov. Dated: December 18, 2024. P. Ritu Nalubola, Associate Commissioner for Policy. [FR Doc. 2024-31305 Filed 12-27-24; 8:45 am]