Food and Drug Administration Center for Biologics Evaluation and Research The Office of Cellular, Tissue and Gene Therapies Web Seminar Series presents: Sponsor Meetings with OCTGT Lori Tull, RAC Regulatory Management Staff

Meetings with OCTGT –FDA meets with sponsors and applicants who seek guidance relating to the development and review of INDs or the review of marketing applications Because these meetings represent critical points in the regulatory process, it is important that there are efficient, consistent procedures for the timely and effective conduct of such meetings.

Types of Meetings –Type A Immediately necessary for a stalled drug development program to proceed Examples are: Dispute resolution, Clinical holds, Special Protocol Assessment Should be scheduled to occur within 30 days of receipt of the sponsor’s complete written request

Types of Meetings (cont.) –Type B Pre-IND meetings, certain end-of-Phase 1 meetings, End-of-Phase 2 and pre-Phase 3 meetings and pre-BLA meetings Should be scheduled to occur within 60 days of receipt of the sponsor’s complete written request Generally, only one of each of the Type B meetings for each potential application will be granted.

Types of Meetings (cont.) –Type C Meetings other than Type A or B Discussions regarding cost recovery, facility design, general product issues, etc. Should be scheduled to occur within 75 days of receipt of the sponsor’s complete written request

Meeting Requests –How to submit Requests for IND, IDE and BLA meetings should be submitted as an amendment to the IND or BLA Pre-IND or pre-IDE meeting requests may be submitted by fax: (301) to the attention of the Branch Chief, Regulatory Management Staff

Meeting Requests (cont.) –Information needed for a request to be considered complete Product name Application number (if applicable) Chemical name and structure Proposed indication(s) or context of product development

Meeting Requests (cont.) –Information needed for a request to be considered complete (cont.) Type of meeting being requested A brief statement of the purpose and objectives of the meeting A proposed agenda A list of proposed questions grouped by discipline.

Meeting Requests (cont.) –Information needed for a request to be considered complete (cont.) A list of all individuals who will attend the proposed meeting from the sponsor's or applicant's organization and consultants. A list of FDA staff requested to participate in the meeting. Suggested dates and times for the meeting that are within the appropriate time from of the meeting type being requested. The format of the meeting (face-to-face or teleconference).

Scheduling the Meeting –If OCTGT agrees to grant the meeting, the meeting will be scheduled and the sponsor/applicant will be notified within 14 days for a Type A meeting and within 21 days for a Type B or C meeting. The faxed response will contain date, time and location of meeting, tentative participants, number of information packages required and date the information packages are due to be received by OCTGT.

Scheduling the Meeting (cont.) –If the meeting request is denied, the sponsor will be notified with an explanation of the reasons for denial –If a meeting is scheduled by FDA and is later canceled or postponed by the sponsor, FDA will consider a subsequent request to schedule the meeting to be a new request.

Information Package –Timing of Submission Type A meetings – 2 weeks before meeting Type B meetings – 4 weeks before meeting Type C meetings – 4 weeks before meeting –Meeting may be postponed or cancelled if adequate supporting documentation has not been received within these time frames

Information Package (cont.) –Content of Submission Summary information relevant to the product(s) Supplementary information needed to develop responses to the sponsor’s questions. Should support the intended objectives of the meeting Should be organized according to the proposed agenda –Insufficient information package may result in meeting cancellation

Information Package (cont.) –The contents of the information package will vary depending on the product, indication, phase of drug development, and issues to be discussed, information packages generally should include: Product name and application number (if applicable). Chemical name and structure. Proposed indication(s). Dosage form, route of administration, and dosing regimen (frequency and duration).

Information Package (cont.) Information Package Contents (cont.) A brief statement of the purpose of the meeting. A list of the specific objectives/outcomes expected from the meeting. A proposed agenda, including estimated amounts of time needed for each agenda item and designated speaker (s) A list of specific questions grouped by discipline.

Information Package (cont.) Information Package Contents (cont.) Clinical data summary (as appropriate). Preclinical data summary (as appropriate). Chemistry, manufacturing, and controls information (as appropriate). –Once the information package is received, the review division will work with the sponsor or applicant to refine the agenda, as appropriate.

FDA Preliminary Responses –When appropriate, OCTGT will fax preliminary responses to the sponsor’s questions from the meeting package and any additional comments one to two days prior to the meeting. If draft responses and advice are sufficiently clear and complete to obviate the need for further discussion, the sponsor may request that the meeting be cancelled.

FDA Preliminary Responses (cont.) Preliminary responses are not intended to generate the submission of a new meeting agenda and new questions. FDA may not be able to provide comments on any new data submitted in response to the preliminary comments.

Conduct of the Meeting –Introductions and statement of the agenda –Presentation from sponsor generally not needed Sponsor should contact project manager if they wish to make a presentation –Discussion focused on FDA responses to sponsor’s questions –Sponsor presents a summary to ensure mutual understanding of meeting outcomes and actions

Meeting Documentation –Official minutes will be issued to the sponsor within 30 days of the meeting –FDA will summarize in bulleted form Important discussion points Decisions Recommendations Agreements/Disagreements Issues for further discussion Action Items

Dispute Resolution –If after receiving official minutes from FDA, a sponsor or applicant needs additional clarificiation, they may contact the project manager for guidance or to arrange a follow-up teleconference.

Dispute Resolution (cont.) –If sponsor wishes to effect a change in the official minutes, they may send a letter to FDA citing their recommendations and rationale. The sponsor’s concern will be taken under consideration by the review division and the project manager will issue an appropriate response in writing.

Dispute Resolution (cont.) –If FDA agrees to change the official minutes, such changes will be documented in an addendum to the official minutes –If sponsors are not satisfied with the response provided by FDA, they may pursue the Agency’s procedures for internal review and dispute resolution.

Guidance –Guidance for Industry: Formal Meetings Between the FDA and Sponsors or Applicants – anceComplianceRegulatoryInformation/Gu idances/UCM pdfhttp:// anceComplianceRegulatoryInformation/Gu idances/UCM pdf