Summary of FDA CBER SOPP 8214: INTERACT Meetings
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The FDA CBER Sopp 8214 outlines the INTERACT process for initial engagement between sponsors and the FDA regarding early-stage drugs and biological products, aiming to provide informal guidance before formal meetings. While participation is optional and not a substitute for formal pre-IND meetings, the INTERACT meetings help identify critical issues in product development and clarify regulatory guidance. Sponsors must meet specific requirements for submitting meeting requests and documents, focusing on early-phase clinical trial elements and product-specific inquiries.
Summary of FDA CBER SOPP 8214: INTERACT Meetings
- 1. Paul Pasco, BA, BS, PharmD Candidate 12 March 2022 Source: U.S. Food & Drug Administration Center for Biologics Evaluation and Research. SOPP 8214: INTERACT Meetings with Sponsors for Drugs and Biological Products. U.S. Food & Drug Administration Center for Biologics Evaluation and Research; 2020:1-13. Accessed March 11, 2022. https://www.fda.gov/media/124044/download Page 1 of 4 Summary of FDA CBER SOPP 8214: INTERACT Meetings with Sponsors for Drugs and Biological Products FDA CBER SOPP 8214, found here, outlines the INTERACT process used by FDA CBER. Text in yellow is important for the candidate product. Text in green is critical for the candidate product. Major areas of discussion are bolded in red. o Overview of INTERACT: • INTERACT = INitial Targeted Engagement for Regulatory Advice on CBER producTs. • Used to provide preliminary, informal, and non-binding guidance to sponsors on a specific product in early-stage development. o Inquiries for formal meetings (e.g., pre-IND meeting) should be relegated to FDA CBER SOPP 8101.1: Regulatory Meetings with Sponsors and Applicants for Drugs and Biological Products here. • Early-stage development is defined as NOT being sufficiently developed to meet criteria for a pre-IND meeting. • Participation in INTERACT is optional. o NOT a substitute (or a prerequisite) for a pre-IND meeting. A pre-IND meeting will still be required at the appropriate time. o That is, the INTERACT process is NOT required during the FDA approval process for a candidate product to be approved. o Purpose of INTERACT: • Will highlight required elements in early-phase clinical trials (i.e., phase I). • Will identify critical issues or deficiencies for sponsors to address in the development of the candidate product. o Scope of INTERACT: • Intended for novel products with unknown safety profiles. • May include questions about chemistry, manufacturing, and controls; pharmacology/toxicology; and/or other clinical aspects of development. This includes: o Specific questions on the adequacy of selected animal models, study design (e.g., appropriate endpoints). o Acceptability of preclinical testing strategies. o Modifications to preclinical study design. o ***Providing recommendations for further development of an early-stage product for which limited data have been collected outside of a U.S. IND.*** • Exclusion criteria: o Only appropriate if the sponsor has an identified product. o If the sponsor has not begun developing a specific product, or there are multiple products under consideration, INTERACT is not appropriate. o ***If the sponsor has questions about the adequacy and/or design of definitive preclinical toxicology studies, an INTERACT meeting is NOT appropriate. Such questions would be addressed during a pre-IND meeting instead.***
- 2. Paul Pasco, BA, BS, PharmD Candidate 12 March 2022 Source: U.S. Food & Drug Administration Center for Biologics Evaluation and Research. SOPP 8214: INTERACT Meetings with Sponsors for Drugs and Biological Products. U.S. Food & Drug Administration Center for Biologics Evaluation and Research; 2020:1-13. Accessed March 11, 2022. https://www.fda.gov/media/124044/download Page 2 of 4 o Questions about specific aspects of clinical study design, rather than preclinical (e.g., inclusion criteria). Such topics would be reviewed at a pre-IND meeting. o If an INTERACT request is submitted under the above circumstances, the FDA will deny the request to meet. More appropriate alternatives will be suggested. o Unless the product has not begun development or the sponsor is considering multiple products, any other denial of meeting requests will be predicated on a substantive reason. ▪ Missing a minor component of the meeting request or package, described further below, is not a substantive reason. ▪ Significant deficiencies in the request or package, such as no questions identified, lack of a package, or multiple omissions in the one provided, would constitute substantive reasons. ▪ Meeting requests may be denied if a different type of meeting would be more appropriate. This may occur if product development is too advanced at this stage. o General requirements of INTERACT: • The sponsor must read SOPP 8214 in preparation for any INTERACT communications (e.g., meeting request, submission of meeting package, live meeting). • If held, the live meeting may NOT be electronically recorded. • To begin the process of communicating with FDA CBER, requests to establish a secure email connection should be addressed to SecureEmail@fda.hhs.gov. This is not the time to request an INTERACT meeting. This is to establish communication only. o Once a secure email relationship has been established, a formal request for an INTERACT meeting may be submitted. o Questions about this may be relegated to SOPP 8119: Use of Email for Regulatory Communications here. o Timeline of INTERACT: • Goals: o Schedule INTERACT meetings within 21-calendar days of requests. o Hold live meetings within 90-calendar days of requests. • The provided time frames are not obligatory for CBER. Actual timeline may be longer subject to CBER availability. o Structure of INTERACT: 2 main components. • (1) A pre-meeting review of documents. o The collection of these documents is called the “meeting package.” o There are strict requirements for the documents submitted. This includes the types of documents, total volume of documents, focused questions for CBER review, and other elements of the meeting package addressed more fully below. o Once the meeting package is submitted, CBER issues a written response to each question posed. • (2) A live discussion. o The sponsor may be fully satisfied with the written responses. If so, the sponsor may send a written request to CBER to cancel the live meeting. CBER comments will be provided to the sponsor no later than 1-calendar day prior to the live meeting.
- 3. Paul Pasco, BA, BS, PharmD Candidate 12 March 2022 Source: U.S. Food & Drug Administration Center for Biologics Evaluation and Research. SOPP 8214: INTERACT Meetings with Sponsors for Drugs and Biological Products. U.S. Food & Drug Administration Center for Biologics Evaluation and Research; 2020:1-13. Accessed March 11, 2022. https://www.fda.gov/media/124044/download Page 3 of 4 o If not fully satisfied, the sponsor may elect to review the responses with FDA CBER staff in a live meeting. This meeting will provide additional clarification about specific questions submitted previously in writing as part of the meeting package. No new questions may be posed. o Only available via teleconference. Lasts approximately 1-hour. o Requirements for meeting requests, packages, and live meeting: • Address all meeting package materials to INTERACT-CBER@fda.hhs.gov. • With consideration of their complexity, all questions submitted in a single INTERACT meeting request must be capable of being reasonably answered within the 1-hour live meeting. • Specify the specific areas where CBER input is requested. • Requests must be succinct. Meeting packages must not exceed 50-pages. • Subject line: o Specify clearly that the sponsor is requesting an INTERACT meeting. o Indicate the CBER office where the request should be directed. ▪ e.g., Office of Communication, Outreach, and Development; Office of Vaccine Research and Review; Office of Compliance and Biologics Quality; etc. ▪ A listing of offices and related contact information may be found here. • Cover letter: o Specify clearly that the sponsor is requesting an INTERACT meeting. o Indicate the CBER office where the request should be directed. A listing of offices and related contact information may be found here. • Body of meeting request: o Describe the product and the disease/condition being treated. o Summarize the product development to date and any future plans for development. o Briefly summarize the purpose of the INTERACT meeting. o Compose a list of questions for CBER grouped by topic. ▪ E.g., chemistry, manufacturing, and controls; pharmacology/toxicology/clinical; etc. o Summarize the importance of each question. Provide any relevant context. o Summarize the relevant data for each question. o Evaluate whether all appropriate disciplines and participants have been included in the documentation for submission. If not, pursue as applicable prior to submitting. o Compose a list of participants, including their titles and affiliations, who will attend the live meeting (if pursued by sponsor). This includes all consultants and interpreters. o Specify availability for the meeting. Include specific dates and times (e.g., morning or afternoon). Include non-availability as applicable. Preferences will be honored in accordance with CBER availability.
- 4. Paul Pasco, BA, BS, PharmD Candidate 12 March 2022 Source: U.S. Food & Drug Administration Center for Biologics Evaluation and Research. SOPP 8214: INTERACT Meetings with Sponsors for Drugs and Biological Products. U.S. Food & Drug Administration Center for Biologics Evaluation and Research; 2020:1-13. Accessed March 11, 2022. https://www.fda.gov/media/124044/download Page 4 of 4 o Important terms for reference: TERM MEANING CBER Center for Biologics Evaluation and Research CMC Chemistry, Manufacturing, and Controls FDA United States Food & Drug Administration INTERACT INitial Targeted Engagement for Regulatory Advice on CBER ProducTs Meeting package The collection of documents submitted to the FDA alongside the request for an INTERACT meeting. Pre-IND meeting Also called a type B meeting or a milestone meeting. A pre-IND meeting is used for a sponsor to discuss a candidate product with the FDA to determine where it stands in the development process. The required components for an IND application are reviewed and the FDA staff provide feedback to the sponsor specific to the candidate product’s package (portfolio). SOPP Standard Operating Policy and Procedure Sponsor The individual, pharmaceutical company, governmental agency, academic institution, or organization seeking approval of a candidate product.