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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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SOPP 8101.1: Scheduling and Conduct of Regulatory Review Meetings with Sponsors and Applicants

Version #5
Effective Date: October 15, 2012

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  1. Purpose
    1. This Standard Operating Policy and Procedure (SOPP) serves as a guide for the Center for Biologics Evaluation and Research (CBER) staff for scheduling and conducting regulatory meetings between individuals in CBER and representatives of the regulated industry (including sponsors/applicants of user fee related products) and/or individual sponsor-investigators to address issues relating to product development.
    2. This SOPP identifies types of meetings and describes actions and responsibilities of CBER personnel for each type.

 

  1. Scope
    1. This SOPP applies to meetings for Investigational New Drugs (INDs), New Drug Applications (NDAs) and Biologics License Applications (BLAs), and their respective amendments and supplements.
    2. For products covered by user fees, the performance goals established in the most current Prescription Drug User Fee Act (PDUFA) Goal letter or Medical Device User Fee Act (MDUFA) Commitment letter will be met.
    3. For products not covered by user fees, the procedures set forth in this document will be used; however the performance goal timelines will be met as resources are available.
    4. For pre-submission meetings, informational meetings and submission issue meetings for medical device submissions other than medical devices licensed under a BLA subject to MDUFA, refer to the Draft Guidance for Industry and FDA Staff: Medical Devices: The Pre-Submission Program and Meetings with FDA Staff (July 2012).
    5. This SOPP does not apply to Biosimilar biological product applications regulated under the Biosimilar User Fee Act (BSUFA) of 2012.
    6. Please refer to SOPP 8104: Documentation of Telephone Contacts with Regulated Industry for additional information.

 

  1. Background
    1. Meetings with industry and sponsor-investigators are a forum for the Agency to provide guidance to representatives of the regulated industry (including sponsors/applicants of user fee related products) and/or individual sponsor-investigators during product development and facility design, and to facilitate their compliance with the regulations governing development and post-approval marketing of products. While meetings are usually requested by sponsors/applicants or individual sponsor-investigators, CBER will occasionally suggest that a meeting be scheduled. Meetings should serve a useful purpose, i.e., should not be premature or clearly unnecessary.
    2. Meetings described in section 119(a) of the Food and Drug Administration Modernization Act of 1997 (FDAMA) are between CBER and a sponsor or applicant for drugs under section 505(b) of the Food, Drug and Cosmetic (FD&C) Act or biologics under section 351(a) of the Public Health Service (PHS) Act that are held for the purpose of reaching agreement on the design and size of clinical trials that are intended to form the primary basis of an effectiveness claim in a marketing application or for validating efficacy under accelerated approval provisions (see 21 CFR 314 Subpart H and 601 Subpart E).
    3. To the extent that section 119(a) of FDAMA requires FDA to meet with a sponsor/applicant requesting a meeting (requester) with regard to a drug that is not a PDUFA product, the procedures, but not the time frames or performance goals, described in this document will apply to any such meeting.
    4. The reauthorization of PDUFA II identified three types of meetings with specific performance goals associated with each type.  The conduct of these meetings is further described in the Guidance for Industry: Formal Meetings between the FDA and Sponsors or Applicants (May 2009).
    5. These meetings may be face-to-face, teleconference, videoconference or written responses.

 

  1. Definitions
    1. Formal Meeting – for purposes of this SOPP, formal meeting includes any meeting requested by a sponsor or applicant (requester) following the procedures provided in this SOPP and Guidance for Industry: Formal Meetings Between FDA and Sponsors and Applicants (May 2009).
    2. Type A Meeting- A meeting which is necessary for an otherwise stalled drug development program to proceed (a “critical path” meeting) or to address an important safety issue. [PDUFA V] Examples of Type A meetings include:
      1. Dispute resolution described in 21 CFR 10.75, 312.48, and 314.103 and in Guidance for Industry Formal Dispute Resolution: Appeals above the Division Level (February 2000).
      2. Clinical holds in which a response to hold issues has been submitted, but CBER and the sponsor agree that the development is stalled; a new path forward should be discussed.
      3. Special Protocol Assessment meetings requested by the sponsor after receipt of CBER’s evaluation of protocols under the Special Protocol Assessment procedures as described in Guidance for Industry: Special Protocol Assessment (May 2002).
      4. Post-action, (i.e., issuance of a complete response letter or denial) meeting within three months after a CBER regulatory action other than an approval. [PDUFA V]
    3. Type B Meeting- Type B meetings include the following:  Pre-IND, End of Phase 1 (for Subpart E or Subpart H or similar products), End of Phase 2/Pre-Phase 3, or a Pre- BLA/NDA meeting. Each requester should usually request only one of each of these Type B meetings for each potential application (BLA/NDA) (or combination of closely related products, i.e., same active ingredient but different dosage forms being developed concurrently). [PDUFA V] Additional information for Type B meetings is included below:
      1. Pre-IND meeting: Occur prior to the submission of an initial Investigational New Drug Application (IND) to discuss the format for the IND, the scope and design of planned Phase 1 clinical studies, design of animal studies needed to support human clinical testing, product characterization issues and the development plan to address requirements for the Pediatric Research Equity Act (PREA) of 2003. (See 21 CFR 312.82).
      2. End of Phase 1 meeting: Occur after completion of early Phase 1 studies to review the Phase 1 data and discuss plans for the Phase 2 program. (See 21 CFR 312 Subpart E, 21 CFR Subpart H, 21 CFR 601 Subpart E, 21 CFR 312.82)
      3. End of Phase 2/Pre-Phase 3 meeting: Held to review the Phase 2 data to discuss whether it is safe to proceed to Phase 3, to evaluate plans for the Phase 3 program and protocols, plans to assess pediatric safety and effectiveness and to identify any additional information necessary to support a marketing application for the uses under investigation. (See 21 CFR 312.47)
      4. Pre-BLA/NDA meeting: To inform CBER of the general information that will be submitted in the marketing application, to discuss preliminary efficacy results derived from studies conducted to support the BLA/ NDA and appropriate methods for final statistical analysis, to discuss the proposed format for data in the planned marketing application, to identify the studies that the applicant will rely on as adequate and well-controlled, plans to assess pediatric safety and effectiveness, to discuss submission of an incomplete application under section 506 of the FD&C Act, and to discuss any major outstanding issues from the IND stage.
      5. Risk evaluation and mitigation strategies (REMS) or postmarketing requirements that occur outside the context of the review of a marketing application. [PDUFA V]
    4. Type C Meeting- Any other type of meeting. [PDUFA V] Examples of Type C meetings include:
      1. Facility/establishment issues discussion prior to submission of the application.
      2. General development discussion of a product.
      3. Cost recovery.

 

  1. Policy
    1. CBER will refer all inquiries regarding meetings to the Guidance for Industry: Formal Meetings between the FDA and Sponsors or Applicants (May 2009), applicable ICH Guidances, and this SOPP.  The requester is expected to have reviewed all relevant documents in preparation for submitting the request and meeting package. For Office specific information, the requester should contact the point-of-contact (POC) in the Applications Division or Regulatory Management Staff in the CBER Office with product responsibility.
    2. The Pediatric Research Equity Act of 2003 (PREA) (amendment to FD&C Act, section 505 and 351 of PHS Act) requires that before and during the investigational process of a new drug or biological product, FDA will meet at appropriate times with the sponsor or applicant to discuss the requester’s plans and timelines for pediatric studies or any planned request for waiver or deferral of pediatric studies.  To assure that the statutory requirements are met in a timely manner, requesters should be advised (at the time the meeting is scheduled) that CBER will be discussing their pediatric development plan, and where applicable, will request this plan (or deferral or waiver request) at the meeting.  The status will be recorded in the meeting minutes. See Draft Guidance for Industry: How to Comply with the Pediatric Research Equity Act (Sept 2005).
    3. For Type C meeting requests to discuss facility/establishment issues prior to submission of the application, the Office of Compliance and Biologics Quality (OCBQ), Division of Manufacturing and Product Quality (DMPQ) will process the request.
    4. For pre-BLA meeting requests for blood establishments, the Office of Blood Research and Review (OBRR), Division of Blood Applications (DBA), Blood and Plasma Branch (BPB) will process the meeting request.
    5. Separate meetings for manufacturing, clinical, and/or establishment issues could be suggested by CBER if the proposed agenda includes extensive discussion of more than one of these topics. CBER may choose to combine agendas of multiple meetings if the objectives can be met in one session.
    6. At PDUFA-related meetings in preparation for a Phase 3 trial, the requester should be reminded of the benefits of requesting a Special Protocol Assessment, if appropriate, in accordance with published FDA Guidance for Industry: Special Protocol Assessment (May 2002).
    7. Pre-IND or Type C meetings
      1. In the case of pre-IND and Type C meeting requests, the requester may request a written response to their questions rather than a face-to-­face meeting, videoconference or teleconference.
      2. In some cases, while the requester may request a face-to-face, videoconference or teleconference meeting, CBER may determine that a written response to the requester’s questions would be the most appropriate means for responding to the meeting request. CBER shall notify the requester of the date it intends to send a response.
    8. Pre BLA/NDA meetings
      1. The purpose of the meeting is to discuss the planned content of the application with the appropriate CBER review division. Applicants are strongly encouraged to request this meeting.  Note: these meetings are Type B meetings. BLA/BLS submissions for a licensed medical device subject to MDUFA should also follow these procedures.
      2. The pre-BLA/NDA meeting should be requested sufficiently in advance of the planned submission of the application to allow for meaningful response to CBER feedback and should generally occur not less than two (2) months prior to the planned submission of the application.Thus, the meeting request should be submitted at least four (4) months prior to application submission. In those cases that an IND was not required, i.e., an exemption described in 21 CFR 312.2(b) is applicable, and therefore a pre-IND meeting was not held, the meeting request should be submitted 2 months prior to the initiation of the supporting studies.
      3. At the pre-BLA/NDA meeting, CBER and the applicant will agree on the content of a complete application for the proposed indication(s), including preliminary discussions on the need for risk evaluation and mitigation strategies (REMS) or other risk management actions. This meeting will be attended by the CBER review team including appropriate senior CBER staff. The agreement and discussions will be summarized at the conclusion of the meeting and reflected in the CBER meeting minutes.
      4. For those products that qualify under the PDUFA V Program:
        1. Senior Staff will include Director and/or Deputy Director of Applications Branch or equivalent, Division Director and/or Deputy of each discipline involved.  Offices may add other more senior staff if they wish. If Director or Deputy of Application Branch or equivalent is not present, a more senior staff member from the Office must attend (e.g. Office Director, Deputy Office Director).
        2. At the meeting, CBER and the applicant may also reach agreement on submission of a limited number of application components not later than 30 calendar days after the submission of the original application.  
          1. These submissions must be of a type that would not be expected to materially impact the ability of the review team to begin its review.
          2. Any such agreement that is reached on delayed submission of application components will be summarized at the conclusion of the meeting and reflected in the CBER meeting minutes.
          3. The requester should be notified that if a late component isn’t received as promised, a Refuse to File letter can be issued.
          4. Examples of application components that may be appropriate for delayed submission include updated stability data (e.g., 15­ month data to update 12-month data submitted with the original submission) or the final audited report of a preclinical study (e.g., carcinogenicity) where the final draft report is submitted with the original application.
          5. Major components of the application (e.g., the complete study report of a Phase 3 clinical trial or the full study report of required long-term safety data) are expected to be submitted with the original application and are not subject to agreement for late submission.
          6. The meeting package should indicate what, if any, information the requester proposes to submit late (within 30 calendar days).
    9. Meeting Request
      1. It is CBER's policy that meeting requests be evaluated promptly, meetings are scheduled and completed within the appropriate goal dates.  The completed meeting request includes the required communications with the meeting requester.
        1. For products covered by user fees, the performance goals established in the most current PDUFA goal letter and MDUFA commitment letter will be met.
        2. For products not covered by user fees, the procedures set forth in this document will be used; however, the performance goals will not apply. CBER will make every effort to respond to meeting requests and meet with sponsor/applicants of non-user fee products as expeditiously as possible.
      2. Only one of each of the Type B meetings for each potential application should be requested, except that in the case(s) when an IND is not required, there may be 2 pre-BLA/NDA meetings. Requests for Type B meetings will be honored except in the most unusual circumstances.
      3. To be considered a complete request, and one that qualifies for the PDUFA or MDUFA performance goals, the submission should be in writing and include at least all items listed below with an asterisk (*). Performance goals are determined based on whether a product is a User Fee or non-User Fee product.
        1. *the product name and application number if already assigned;
        2. *chemical name and structure (if appropriate). If chemical name and structure is not appropriate, please include a description of your product;
        3. *proposed indication;
        4. *type of meeting being requested (Type A, B or C);
        5. *a brief statement of the purpose of the meeting;
          1. including a description of the types of studies or data that the requester plans to discuss at the meeting.
          2. for new products, include a description and the developmental status of the product.
        6. *a listing of the specific objectives or outcomes that the requester expects;
        7. a proposed agenda, including estimated times needed for each agenda item;
        8. *a list of proposed questions (grouped by discipline).  CBER recommends that for each question there should be a brief explanation of the context and purpose of the question;
        9. *a list of planned external non-FDA attendees.  CBER should be given pre-notification of all attendees;
        10. a list of requested participants or disciplines to be represented from the Center;
        11. Requested format of meeting, e.g., face-to-face, teleconference, videoconference or written format;
        12. *Suggested dates for the meeting;
        13. Suggested duration of the meeting.
    10. Scheduling the meeting (if there is agreement for the meeting to proceed):
      1. If the meeting date requested is beyond the goal date for the type of meeting being requested, CBER will work with the requester to determine the earliest agreeable date.
      2. For products not covered by user fees, CBER will make every effort to respond to meeting requests and meet with sponsor/applicants of non-user fee products as expeditiously as possible.
      3. Current meeting goals for PDUFA and MDUFA (BLA/BLS only) products:
        1. Type A meetings
          1. Will be scheduled within 14 calendar days of receipt.
          2. Should occur within 30 calendar days of receipt of the request.
        2. Type B meetings
          1. Will be scheduled within 21 calendar days of receipt.
          2. Should occur within 60 calendar days of receipt of the request.
          3. In the case of a written response for a pre-IND meeting, the response should be transmitted by CBER within 60 calendar days of the Agency receipt of the meeting request.
        3. Type C meetings
          1. Will be scheduled within 21 calendar days of receipt. 
          2. Should occur within 75 calendar days of the receipt of the request.
          3. In the case of a written response, the response should be transmitted by CBER within 75 calendar days of the Agency receipt of the meeting request.
      4. The Meeting Scheduling Memorandum will include:
        1. The confirmed date, time, location and format of meeting, for example, if the format will be face-to-face, teleconference, videoconference or written responses.
        2. The number of required copies of pre-meeting materials.
        3. As appropriate, a request to include an update of their pediatric development plan (or intent to request deferral or waiver).
        4. Date meeting package is to be submitted. The requester should be notified that failure to submit adequate meeting materials by the appropriate date could result in meeting cancelation.
        5. The date for an expected response if the requester specifies a format of written response only and CBER agrees with the requester.
    11. Meeting Packages
      1. Should be prepared by the requester and submitted to CBER.
        1. For products that qualify under PDUFA V or MDUFA III (BLA/BLS only):
          1. For a Type A meeting, the meeting package should be received at the time of the request.
          2. For a Type B or Type C meeting, the meeting package should be received not less than one month (30 calendar days) prior to the meeting.
        2. For all other products:
          1. For a Type A meeting, the meeting package should be received not less than two (2) weeks (14 calendar days) prior to the meeting.
          2. For a Type B or Type C meeting, the meeting package should be received not less than one month (30 calendar days) prior to the meeting.
      2. Should provide summary information relevant to the product(s), plus supplementary information to enable the development of responses to issues raised by the requester or reviewing division to meet the objectives of the meeting.
        1. Pre-IND meeting - a summary of manufacturing information including completed or proposed testing and specifications; any pre-clinical studies completed or proposed; any known experience with the product in humans; the proposed eventual clinical use with rationale; a reasonably complete protocol or protocol synopsis; and information on any unique characteristics which differentiate the product from other similar entities. The requester is expected to submit their development plan for complying with PREA.
        2. End of Phase 1 meeting – a summary of data obtained in the Phase 1 study and the proposed Phase 2/Phase 3 development plan. 
        3. End of Phase 2/Pre-Phase 3 meeting - a synopsis of data from studies completed to date and proposed Phase 3 protocol(s) including detailed statistical plan. Outlines of any contractual arrangements for product manufacture and details of the characterization of the product to be used in the studies should also be submitted. If the Phase 3 product is not the same as the product intended for the market, proposals for studies to determine the comparability of the products are necessary. The requester is expected to submit their development plan for complying with PREA.
        4. Pre-BLA/NDA meeting - a summary of the data from the pivotal studies completed; the proposed indication; proposed format of the submission, manufacturing information on the products used in the study(ies) and product intended for distribution if different; outlines of any contractual arrangements for product manufacture, proposed format of the submission and a timeline for submission. The requester is expected to submit their development plan for complying with PREA. For products that qualify under the PDUFA V Program, the requester should also include what, if any, information the company proposes to submit late (within 30 calendar days).
        5. Establishment issues meeting - identification of the product(s) produced with a brief description of the manufacturing process; a production process flow chart; floor plans with manufacturing process, personnel flow, water system, water and heating, ventilation, and air conditioning (HVAC) system, air pressure differentials, and air qualities described; a brief description of HVAC systems; changeover procedures and product/personnel separation information for multi-use facilities; a brief description of validation procedures including the validation master plan; and any unique issues pertinent to the facility.
      3. If additional information is received after receipt of the meeting package, CBER may inform the requester that the new information or questions will not be reviewed or answered.  The meeting will proceed as scheduled with only the meeting package information/questions.  Discussion of the additional information may be the subject of a subsequent meeting.
    12. Reasons a meeting may not be held
      1. The request for a meeting may be denied. Examples of reasons for denial are included below:
        1. The meeting request is substantially incomplete, based on the omission of one of more of the elements identified with an asterisk (*); see I (3) above
        2. The meeting is premature for the stage of development.
        3. A previous meeting for the same purpose has already been held, and no substantially new information has become available.
        4. The requested feedback would be best provided through another process, for example, the Office of Combination Products.
      2. The meeting may be rescheduled by CBER and a new date immediately identified. If the meeting is rescheduled, the requester will be notified by telephone or other rapid means of communication followed by a written confirmation. Examples of reasons for rescheduling a meeting include:
        1. The requester asked to reschedule the meeting and a new date is immediately identified.
        2. The package was not received by the PDUFA or MDUFA goal date.
        3. The package is too voluminous (for example, more than 300 pages) to review prior to the original meeting date.
        4. The package includes an excessive number of questions (for example, more than 10 for any one discipline or a total of more than 50 for all disciplines) that could not be addressed effectively in the meeting time allotted.
        5. Additional consult reviewers or management input is needed, but cannot be obtained prior to the original meeting date.
        6. Required CBER attendees become unexpectedly unavailable and appropriate substitutes cannot be identified. CBER reschedules the meeting and the new date is readily identified.
        7. CBER may reschedule the meeting, and immediately identify a new meeting time, to allow for additional review time if additional information was received after receipt of the meeting package.
      3. The meeting may be canceled by CBER.  If the meeting is canceled, the requester will be notified by telephone or other rapid means of communication followed by a written confirmation. Examples of reasons for canceling a meeting include:
        1. The package was not received by the PDUFA or MDUFA goal date.
        2. The package is inadequate to enable CBER to provide meaningful responses to the questions.  Examples of this situation include questions that are either vague or premature for meeting type.
        3. Additional reasons for cancelation:
          1. Requester is satisfied with the CBER pre-meeting (preliminary) responses and cancels the meeting.  If the requester wants to cancel the meeting, a written confirmation should be sent to CBER.
          2. The requester asks to cancel the meeting for any other reason.
    13. Internal Meetings
      1. An internal meeting, prior to the formal meeting with a requester, will also be scheduled. The internal meeting is an opportunity for the FDA to formulate a consensus on its responses to the requester’s questions and to identify additional issues or comments to share with the requester.
      2. This internal meeting should include all persons invited to attend the meeting with the requester. Reviewers who did not attend the internal meeting or provide comments for the internal discussion are discouraged from participating in the formal meeting.
      3. Post-Internal meeting prior to the formal meeting:
        1. CBER will send, when possible, pre-meeting (preliminary) responses to the requester no later than 24 to 48 hours before the formal meeting using regulatory template T 820.04: Meeting Response. [RPM]
        2. The Meeting Response should clarify that the responses are not final until CBER and the requester agree that no further discussion is needed.
    14. Meeting Minutes
      1. CBER minutes are the official record of the meeting and should be issued no later than 30 calendar days following the meeting.
      2. Meeting minutes reflect discussions that occurred during the meeting.
        1. A section clearly identifiable as information not having been discussed during the meeting, e.g., ‘Post-meeting comments,’ should be included as necessary.  Examples of this type information includes:
          1. CBER responses to Action Items offered to be provided in the minutes.
          2. Clarification of comments made by CBER during the meeting.
      3. The meeting requester is responsible for notifying CBER of any significant differences in their understanding of the meeting outcomes (as reflected in the official CBER minutes).
        1. CBER will make every effort to resolve differences in the minutes and the understanding of the meeting outcomes identified by the requester. This does not include discussion of new or alternative questions from those that were addressed during the meeting. Requests for evaluation of an alternative approach represent a new request for an additional meeting.
        2. If after discussions with the requester CBER deems it necessary to effect a change to the official minutes, the changes will be documented in an addendum to the official minutes. The addendum will also document any continued requester objections.
        3. If policy issues or requirements related to a particular application that emerge during or after a formal meeting cannot be resolved at the office level that held the meeting, the dispute resolution process may be invoked by the requester.
      4. Requester’s meeting minutes
        1. In accordance with 21 CFR 10.65(f), the requester, or other meeting participant, may prepare and submit to CBER a memorandum summarizing their understanding of issues discussed at the meeting. This memorandum, if provided by the requester, should be included along with CBER's summary in the administrative record.
          1. Drafts of meeting minutes prepared by the requester are not the official minutes of the meeting.
          2. Minutes prepared by the requester may or may not be considered during the preparation of the official CBER minutes.

 

  1. Responsibilities
    The responsibilities listed below are those related to this SOPP only.
      1. Chair - Coordinates with the RPM formal meetings with sponsors/applicants as outlined in this SOPP. Note: The Cross Discipline Team Leader (CDTL) as referred to in the PDUFA V Program is the same as the Chair within CBER.
      2. Document Control Center (DCC) –processes all incoming meeting requests and meeting packages, including loading electronic submissions into CBER’s Electronic Document Room (EDR), routing and filing paper submissions.
      3. Office Management – Supervisory chain, including Division Directors or designees within a Division that evaluates the meeting request and makes the decision on whether or not to hold the meeting, participates in the evaluation of the meeting package, participates in the meeting, and works with the review committee as necessary.
      4. Regulatory Information Specialist (RIS) – Coordinates with the RPM to schedule and organize the meeting.
      5. Regulatory Project Manager (RPM) – Responsible for the overall management of the meeting request. These responsibilities include: reviewing assigned sections, ensuring the requested meeting and associated internal meetings are scheduled; ensuring regulatory and administrative actions are completed on time, including all notifications to requester, performs quality control checks, ensures all communications are entered in the appropriate regulatory database and imported into CBER’s Electronic Document Room (EDR) and ensures the file is administratively complete.
      6. Review Committee Member - Reviews meeting requests and packages, participates in internal and formal meetings, provides comments for the internal discussion, pre-meeting responses and/or written responses, performs and documents a review of the submission that is scientifically sound and follows Good Review Management Practices.

 

  1. Procedures
    1. Processing a meeting request
      1. Forward all meeting requests to the Application Division or Regulatory Management Staff of the appropriate Office, according to the list below. [DCC]
        1. Office of Biostatics and Epidemiology (OBE), Division of Epidemiology (DE);
        2. Office of Blood Research and Review (OBRR), Division of Blood Applications (DBA);
        3. Office of Cellular, Tissue, and Gene Therapies (OCTGT), Regulatory Management Staff (RMS);
        4. Office of Compliance and Biologics Quality (OCBQ), Division of Manufacturing and Product Quality (DMPQ);
        5. Office of Vaccines Research and Review (OVRR), Division of Vaccines and Related Products Applications (DVRPA);
      2. Coordinate the meeting request. [RPM, RIS]
        1. Act as the contact person between the Agency and the outside requester. [RPM]
        2. Notify and coordinate with other staff, as needed. [RPM, RIS]
        3. Refer to regulatory job aid JA 910.09: Pre-Submission Meetings for BLAs and NDAs for additional information, as appropriate.
      3. Ensure that the necessary information is entered into the appropriate regulatory database and the CBER Regulatory Meetings Tracking System (CRMTS). [RPM, RIS]. Note:  All meeting requests are, upon receipt, entered into the database. 
        1. CRMTS will generate a unique Meeting ID when the information is saved. Request the applicant use the Meeting ID number when sending in the meeting package. The Meeting ID number should be used for all correspondence with the applicant once the meeting is requested.  [RPM, RIS]
        2. If the meeting request is not related to a pending submission, ensure that the relevant information is completed in the Pre-application Tracking (PTS) module in the Biologics Information Tracking System (BITS). Refer to the BITS User Guide for additional information. [RPM, RIS]
      4. Evaluate the initial request for completeness based upon the elements listed in the policy section of this SOPP.  See regulatory job aid JA 820.07: Evaluating the Meeting Request for additional information.  [Office Management, Review Committee Members]
      5. Make the decision on whether or not the meeting will be held. [Division Director or designee]
      6. Notify the requester of CBER’s decision. [RPM, RIS]
        1. CBER will notify the requester of their assessment of the meeting request, granting or denying the meeting, within 14 calendar days of receipt of the request for a Type A meeting and within 21 calendar days for Type B and Type C meetings.
        2. CBER will notify the requester within 21 calendar days if the decision was made to send written responses.
        3. Inform the requester what is necessary to initiate the process of scheduling a meeting if the request is incomplete. [RPM, RIS]
      7. If there is agreement the meeting should not proceed:
        1. Notify the requester that the meeting request is denied using regulatory template T 820.07: Meeting Denied[RPM]
        2. Update CRMTS with the appropriate information. [RPM, RIS]
      8. If there is agreement the meeting should proceed:
        1. Ensure all appropriate persons are identified and invited to attend both the internal and formal meeting. FDA attendees may include reviewers, Division Directors, Associate Directors for Policy, statistician(s), representatives from OCBQ as well as experts from other Centers. Ensure information is added to the appropriate Office calendar. [RPM, RIS]
        2. Update CRMTS and the relevant database with all appropriate information. [RPM, RIS]
        3. Notify the requester using regulatory template T 820.03: Meeting Confirmation. [RPM, RIS]
    2. Internal meeting
      1. Preparing for the meeting:
        1. Forward all meeting packages to the Application Division or Regulatory Management Staff of the appropriate Office, according to the list in Section VII.A.1. [DCC]
        2. Receive and distribute meeting packages to the review team and office management. [RPM, RIS]
        3. Evaluate meeting package. [Review Committee Members, Office Management as appropriate]
        4. Evaluate whether all appropriate disciplines and participants, including Special Government Employees (SGEs), have been included (CBER internal meeting and formal meeting with requester). [RPM, Review Committee Chair]
        5. Review the meeting package prior to the meeting. [Meeting Attendees] Note: Persons unable to attend the internal meeting are expected to submit comments for the pre-meeting (preliminary) responses. Reviewers unable to attend the internal meeting and do not submit comments for the internal discussion are discouraged from participating in the formal meeting. If appropriate, an alternate may participate in the internal meeting and participate in the formal meeting.
        6. Engage in communications among themselves to develop their responses if additional collaboration prior to the internal meeting is needed. [Review Committee Members, Office management]
        7. Draft responses to the requester’s questions and submit them for committee review at least 24 hours prior to the internal meeting. [Review Committee Members]
      2. Meeting (CBER internal)
        1. Discuss issues that arise during the review of the meeting package in addition to the questions receivedby the requester. [Review Committee Members]
        2. Ensure CBER responses to the internal meeting are discussed and resolved.[RPM, Review Committee Members]
        3. Ensure specific assignments, including roles and responsibilities, are defined for FDA/CBER staff to follow during the formal meeting.  A leader should be designated, reviewers should be aware of the questions they will address, and the meeting recorder designated. [Review Committee Members]
        4. Make decision during the meeting whether written responses only are to be sent and whether the formal meeting will be rescheduled or canceled. [Review Committee Members]
        5. Notify requester of rescheduled or canceled meeting. [RPM]
        6. Notify requester of change of meeting format and date when responses will be provided if CBER decided to send written responses only. Refer to regulatory job aid JA 820.03: Written Responses to Pre-IND or Type C Meeting Requests for additional information.[RPM]
      3. Preparing CBER pre-meeting (preliminary) responses:
        1. Ensure comments for the responses are forwarded to the RPM. [Review Committee Members]
        2. Ensure responses are circulated for comment. [RPM]
        3. Review and comment on responses prior to issuance to the requester. [Review Committee Members] Note: Persons who were unable to attend the internal meeting are responsible for reading and commenting on the responses prior to issuance.
        4. Finalize responses, including routing through review committee as appropriate. [RPM]
    3. Written responses
      1. These procedures are followed when the written responses are sent to the requester with no expectation of a formal meeting:
        1. Send written responses to the requester by the date specified in the current user fee goals date letter (for PDUFA or MDUFA products) using regulatory template T 820.04: Meeting Response. [RPM]
        2. Update information in appropriate regulatory databases. [RPM, RIS]
      2. These procedures are followed when the pre-meeting (preliminary) responses are sent to the requester with the expectation of holding the formal meeting. [RPM, RIS]
        1. Send responses to the requester no later than 24 to 48 hours before the formal meeting using regulatory template T 820.04: Meeting Response.
        2. Include a request for a response to CBER confirming the requester’s plan for proceeding with the formal meeting.
      3. If the requester sent written confirmation of their decision to cancel the meeting:
        1. Notify FDA/CBER attendees of cancelation. [RPM]
        2. Notify requester of cancelation using regulatory template T: 820.09: Meeting Cancelation. [RPM]
        3. Ensure all relevant databases are updated. [RPM]
      4. If the requester wants to proceed with the formal meeting:
        1. Notify appropriate FDA/CBER attendees of the meeting status and possible changes to the meeting agenda. [RPM]
        2. Ensure all relevant databases are updated. [RPM]
    4. Post meeting activities
      1. Draft a meeting summary and ensure it is reviewed and finalized using regulatory template T 820.06: Meeting Summary. [RPM, Review Committee Members]
      2. Ensure all meeting attendees and supervisors review and agree on the draft minutes prior to finalizing. [RPM]
      3. Ensure the finalized meeting summary is transmitted to the requester within 30 calendar days of the formal meeting. [RPM, RIS] Note: The meeting summary may be transmitted to the requester by mail or fax using regulatory template T 820.05: Meeting Summary Cover Sheet.
      4. Coordinate the appropriate response (e.g., guidance on a course of action or arranging a teleconference) if clarification is requested for items in the official minutes.  [RPM]
      5. Any changes to the official minutes, after discussion with the requester, will be documented in an addendum to the official minutes. The addendum will also document any continued objections raised by the requester. [RPM]
      6. Resolve differences that may be identified by the requester between CBER’s minutes and the requester’s understanding of the meeting outcomes. Refer to SOPP 8005: Major Dispute Resolution as appropriate. [Division Director or designee]
      7. Enter all communications with the requester in the appropriate regulatory database and import into CBER’s EDR. [RPM, RIS]
    5. Meeting rescheduled
      1. Notify requester by telephone or other rapid means of communication followed by a written confirmation using regulatory template T820.08: Meeting Rescheduled. [RPM]
      2. Update all appropriate regulatory databases. [RPM]
      3. Notify FDA/CBER attendees. [RPM]
    6. Meeting cancelation
      1. Notify requester by telephone or other rapid means of communication followed by a written confirmation using regulatory template T820.09: Meeting Cancelation. [RPM]
      2. Update all appropriate regulatory databases. [RPM]
      3. Notify FDA/CBER attendees. [RPM]

 

  1. Appendix
    N/A

 

  1. References  
    1. References below are located on CBER’s Intranet Web page (unless otherwise noted):
      1. Regulatory Job Aids:
        1. JA 820.03: Written Responses to Pre-IND or Type C Meeting Requests
        2. JA 820.07: Evaluating the Meeting Request
        3. JA 910.09: Pre-Submission Meeting for BLAs and NDAs
      2. Regulatory Templates:
        1. T 820.03: Meeting Confirmation
        2. T 820.04: Meeting Response
        3. T 820.05: Meeting Summary Cover Sheet
        4. T 820.06: Meeting Summary
        5. T 820.07: Meeting Denied
        6. T 820.08:Meeting Rescheduled
        7. T 820.09: Meeting Cancelation
      3. CBER  Regulatory Meetings Tracking System Database (CRMTS) User Guide
      4. Biologics Information Tracking System (BITS) User Guide
    2. Web links to the references below can be found in the list following the History Table
      1. Federal Food Drug and Cosmetic (FD&C)
      2. Public Health Service Act (PHS)
      3. Pediatric Research Equity Act of 2007 (PREA)
      4. 21 Code of Federal Regulations
      5. Food and Drug Administration Modernization Act of 1997 (FDAMA)
      6. Prescription Drug User Fee Act (PDUFA)
      7. PDUFA V goals letter
      8. Medical Device User Fee Amendments (MDUFA III) 2012
      9. Guidance for Industry: Formal Meetings With Sponsors and Applicants for PDUFA Products (February 2000)
      10. Draft Guidance for Industry: How to Comply with the Pediatric Research Equity Act (September 2005)
      11. Guidance for Industry: Special Protocol Assessment (May 2002)
      12. Guidance for Industry: Formal Dispute Resolution: Appeals above the Division Level (February 2000)
      13. Draft Guidance for Industry and FDA Staff: Medical Devices: The Pre-Submission Program and Meetings with FDA Staff  (July 2012)
      14. SOPP 8005: Major Dispute Resolution Process
      15. SOPP 8104: Documentation of Telephone Contacts with Regulated Industry 

     

  2. History
Written/ RevisionApprovedApproval DateVersion NumberComment
Linda Dixon, Working GroupRobert Yetter, PhDOct 5, 20125Updated to include PDUFA V information and updated procedures

Leonard Wilson/ Lydia Falk

Robert Yetter, PhDMay 4, 20074Updated to include updating the status of PREA studies and Quality System implementation
Leonard WilsonRobert Yetter, PhDDec 23, 20023Updated mail code and appendix 1; added references to PDUFA 3
Robert Yetter, PhDRobert Yetter, PhDAug 15, 20022Added reminder for sponsors to use Special Protocol Assessment (SPA); added link as appendix; revised appendices numbering
RMCCRebecca DevineFeb 11, 19991Original Document