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  1. Development & Approval Process (CBER)

Formal Meetings and Requests for Feedback for CBER-Regulated Products

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professionals meeting in conference room

Introduction

This webpage serves as a resource for CBER stakeholders to find information on formal meetings, determine if a meeting with CBER needs to be requested, what type of meeting is appropriate, and how to submit a meeting request.

PDUFA Meetings

For products that are subject to the Prescription Drug User Fee Act (PDUFA), formal meetings between the Food and Drug Administration (FDA) and sponsors or applicants are a forum to discuss issues related to the development and review of FDA-regulated products. Meeting types and meeting formats are defined within the Definitions section of SOPP 8101.1.

Formal meetings can be conducted in person face-to-face, virtual face-to-face (video conference only), teleconference, and written response only (WRO).  All in person face-to-face meetings will have a virtual component. WRO can be requested and sent in lieu of holding a face-to-face (in-person or virtual) meeting or teleconference. CBER will make every effort to grant the requested format. However, CBER may determine a WRO to be more appropriate for some meetings based on several factors. Considerations for converting meeting requests to a WRO are referenced within Appendix D of SOPP 8101.1. Meeting Management Procedural Goals can be found in tables within the Appendices of SOPP 8101.1.

NOTES:

  • Requestors are encouraged to submit meeting requests electronically via the FDA Electronic Submissions Gateway (ESG) to CBER for all CBER-regulated products.  
  • For CBER-regulated products that are not subject to PDUFA, the performance goals will not apply. However, CBER will make every effort to respond to meeting requests and meet with sponsors/applicants of non-user fee products as expeditiously as possible.

MDUFA Requests for Feedback

For products subject to Medical Device User Fee Act (MDUFA), submitters can request feedback in writing or a meeting with the Food and Drug Administration (FDA), through the Q-submission (Q-sub) program, regarding:

  • Potential or planned medical device Investigational Device Exemption (IDE) applications
  • Premarket Approval (PMA) applications
  • Humanitarian Device Exemption (HDE) applications
  • Evaluation of Automatic Class III Designations (De Novo requests)
  • Premarket Notification (510(k)) Submissions
  • Accessory Classification Requests 
  • Certain Investigational New Drug Applications (INDs) and Biologics License Applications (BLAs) submitted to the Center for Biologics Evaluation and Research (CBER) (specifically, INDs and BLAs for devices that are regulated as biological products under section 351 of the Public Health Service (PHS) Act)

Review guidance and FAQs for information regarding the types of requests for information and meetings that are appropriate for your circumstance.

Note for Combination Products: The type of meeting requested for a Combination Product depends on the primary mode of action. If the biologic/drug is the primary mode of action, submit a meeting request per PDUFA. For devices, submit your request per MDUFA.

Early Engagement with CBER

Sponsors who are pursuing novel products can engage directly with CBER early in product development to discuss critical aspects of their development program and seek advice on the data required in support of their upcoming submission. There are three types of meetings that offer an early engagement option with the FDA:

INTERACT MEETING

INTERACT or an Initial Targeted Engagement for Regulatory Advice on CBER/CDER ProducTs meeting is an opportunity for sponsors developing first-in-human use of novel therapies to request feedback at an early stage of development prior to a pre-IND meeting request and before submission of an IND. Before requesting an INTERACT meeting, a sponsor should have an early product characterization and pre-clinical proof-of-concept studies with the intended investigational product.

PRE-IND MEETING

Although not required for an Investigational New Drug Application (IND) submission, the pre-IND meeting is intended to support preparation of a high-quality IND submission. The primary purpose of a Pre-IND Meeting is to review and obtain feedback on the design of preclinical studies, the design of the initial IND study, and product manufacturing and quality controls needed to initiate human studies. The meeting may also provide an opportunity to discuss further plans for studying the product in pediatric populations, the target product profile, the design and results of any natural history studies, and the format of data submitted in the IND.

CBER ADVANCED TECHNOLOGIES TEAM (CATT) MEETING

CBER CATT promotes dialogue, education, and input among CBER staff and between CBER and innovators/developers of advanced manufacturing technologies. The CATT meetings focus on novel technologies that could have a significant impact on product development, manufacturing processes and control strategies. Furthermore, application of these technologies may also have potential regulatory implications.

Note: CATT meetings are informal, therefore the PDUFA performance goals will not apply, and advice provided by CATT is non-binding. For more information visit: CBER Advanced Technologies Team (CATT) | FDA.

Frequently Asked Questions (FAQs)

PDUFA

  1. Q: Do I need a PDUFA meeting with CBER?

    A: Before requesting a meeting, sponsors/applicants should use the extensive publicly available product development information (e.g., guidance documents) . If the adequate answers cannot be found and further guidance is needed, a request for a meeting or written response can be submitted to CBER. 
    Note: For questions that may not warrant a meeting, reach out to the RPM assigned and follow up with an amendment to your submission. CBER will respond to your question via secure email as time and workloads allow.

  2. Q: I’m developing a product subject to PDUFA, and I need a formal meeting with CBER, what type of meeting is appropriate?

    A: There are several types of formal meetings that a sponsor/applicant can request with CBER. Meeting types are defined within the Definitions section of SOPP 8101.1. The nature and complexity of the questions, stage in product development, and type of product are examples of what should be considered in determining the appropriate kind of meeting to request. The proposed meeting type should be specified in the meeting request. For more information on formal meetings with the FDA, see the Draft Guidance for Industry: Formal Meetings between the FDA and Sponsors or Applicants of PDUFA Products.

  3. Q: What if I request the wrong meeting type?

    A: After reviewing the meeting request, if CBER determines that a different meeting type is more appropriate, when possible, the meeting may be converted to the more appropriate meeting type, and the requestor will be notified in writing.

  4. Q: Will my meeting be virtual or in-person?

    A: The meeting requester should propose a desired meeting format in their meeting request. While CBER will make every effort to grant formal meetings in the format requested, the final determination of the format will be made by the review division and communicated to the requestor, if the meeting is granted. Meeting formats are defined within the Definitions section of SOPP 8101.1.

  5. Q: How do I submit a PDUFA meeting request?

    A: Requestors are encouraged to send meeting requests electronically via the FDA Electronic Submissions Gateway (ESG) to CBER. When requested, CBER will issue a tracking number in advance of electronic submissions in eCTD format. Requests should be made by email to CBERRIB@fda.hhs.gov.
    Requests that are not required to be submitted in the Electronic Common Technical Document (eCTD) format via the ESG can be emailed as a PDF submission to CBERDCC_eMailSub@fda.hhs.gov (150MB max).

    Electronic or secure email submission is preferred, but requestors may submit paper or electronic media (USB drive, CD, DVD) documents and other regulatory correspondence to the Document Control Center at CBER mailing address:

    U.S. Food and Drug Administration
    Center for Biologics Evaluation and Research
    Document Control Center
    10903 New Hampshire Avenue
    WO71, G112
    Silver Spring, MD 20993-0002

    Additional information on regulatory submissions to CBER can be found at the following website: https://www.fda.gov/about-fda/about-center-biologics-evaluation-and-research-cber/regulatory-submissions-electronic-and-paper.

  6. Q: What if I need clarification on CBER's meeting responses following receipt of a meeting summary or WRO?

    A: Submit a “Request for Clarification” to the CBER within 20 calendar days following receipt of the meeting summary or a WRO. Do not submit new questions in your request, only clarifying questions will be subject to these timelines. CBER will issue a response in writing within 20 calendar days of receipt of clarifying questions. 
    To obtain clarification for a single meeting response, limited to one discipline, sponsors may submit a question to the agency through the RPM. FDA will strive to issue a response via email within 3 business days.
    Note: Contact the Regulatory Project Manager assigned to your meeting if you note any significant differences in your understanding of the meeting outcomes described in CBERs meeting minutes.
     

  1. Q: How do I submit a request for feedback/meeting request to CBER?

    A: Review the FDA Guidance: Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program for detailed information on preparing your Q-sub meeting request. Use the CDRH Premarket Review Submission Cover Sheet and include in your submission to facilitate identification of the meeting type and prompt routing to the appropriate review group within CBER.

    You must submit an eCopy of your Q-Sub under section 745(A)(b) of the FD&C Act.

    For more information on eCopy and the submission process, visit: https://www.fda.gov/medical-devices/how-study-and-market-your-device/ecopy-program-medical-device-submissions, and review the guidance: eCopy Program for Medical Device Submissions.

    For Pre-Submissions (pre-subs), you may use the process above OR utilize the electronic Submission Template and Resource (eSTAR) available on the FDA eSTAR Program website to prepare your pre-sub.

  2. Q: When does the review clock start on a Q-sub request?

    A: The FDA review clock starts when a valid eCopy of the request is received by CBER. For Q-Subs with an acceptance review, if the file is incomplete and is placed on hold, the review clock will begin upon receipt of the amendment that is accepted for review.

  3. Q: How many Pre-submissions (pre-subs) can I submit for a single submission?

    A: There is no limitation on the number of pre-subs for a single device submission. However, you cannot submit more than one pre-sub at the same time.

  4. Q: Is it mandatory to have a Pre-submission (pre-sub) meeting with the FDA before a premarket notification?

    A: The pre-sub program is completely voluntary; however, early interaction with the FDA is encouraged.

Regulatory Meetings Processes:

PDUFA Products:

BsUFA Products:

MDUFA Products:



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