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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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SOPP 8401.3: Filing Action: Communication Options

Version #2

Effective Date: August 4, 2010


    1. Purpose
    1. The purpose of this document is to describe the procedures and communication options for Center for Biologics Evaluation and Research (CBER) staff for informing an applicant of issues identified during the filing review of a Biologics License Application (BLA) or New Drug Application (NDA) or BLA/NDA efficacy supplement.
    1. Background
    1. When an application or a supplement is submitted, it is reviewed according to Center procedures (SOPP 8404: Refusal to File Procedures for Biologic License Applications) to determine if it is sufficiently complete to allow meaningful review. The filing review is conducted by the review team during the first 60 days of the review clock. If it is determined that the application can be filed, the application review continues. If CBER refuses to file the application, the applicant is notified of that decision and CBER's reasons for not filing the submission.

      The Prescription Drug User Fee Act , as amended in PDUFA III, contained new agreements between FDA and applicants that stated at the completion of the filing review for a new drug applications, biologics license applications, and efficacy supplements, FDA will:

      • communicate to applicants substantive deficiencies identified during the filing review or
      • if FDA does not find such deficiencies, FDA will so notify the applicant.

      The agreement also explicitly acknowledged that the filing review is a preliminary review and is not indicative of deficiencies that may be identified later in the review cycle. Furthermore, some deficiencies noted during the filing review may be resolved based on a completed review. Therefore, communication to the applicant concerning deficiencies noted during the filing review should clearly indicate that this is a preliminary assessment of the application contents.  Procedures for deficiencies found outside the filing review are found in SOPP 8401.1: Issuance and Review of Responses to Information Requests and Discipline Review Letters to Pending Applications.  If there are issues identified during the filing review, these issues will be communicated to the applicant in the filing letter or within 14 calendar days after the 60 day filing date.

      Under the PDUFA IV goals, the Agency agreed to notify the applicant of an original NDA/BLA application or efficacy supplement of the planned target date for communication of feedback in the filing letter.  Issues may include proposed labeling and postmarketing study requirements or commitments (PMRs/PMCs) the Agency may request.   The planned review timeline, based on the application as submitted, will be included in the filing letter.

    1. Definitions

      User Fee goal date (PDUFA action due date): the date by which an action is due on a marketing application under the time frames negotiated as a result of the Prescription Drug User Fee Act of 1992 (PDUFA) and subsequent legislation amending that act.

      Planned review timeline: the planned dates for key review milestones for an application.  For purposed of this SOPP, these milestones include the target dates for communication from the review division to the applicant regarding proposed labeling and postmarketing study requirements/commitments (PMRs/PMCs).

    2. Policy
    1. It is CBER policy that

      • A filing letter will be issued by day 60
      • Potential issues (or lack thereof) identified during the filing review in applications or supplements that are filed will be communicated to applicants by day 74 of the review clock;
      • Potential issues (or lack thereof) will be communicated in writing, either by letter, facsimile or secure email, and will be documented in the application record;
      • A target date for proposed labeling and postmarketing study requirements or commitments (PMRs/PMCs) the Agency may request will be communicated by the Agency to the applicant in the filing letter.
      • CBER's performance in meeting the 74-day goal for communication of filing issues and target dates for proposed labeling and PMRs/PMCs discussion will be tracked and reported in the agency's annual report on PDUFA performance.

    1. Responsibilities and Procedures
    1. Review Committee:

      • Reviews the submission and makes the recommendation whether or not to file the submission.
      • Identifies any substantive deficiencies, including labeling deficiencies to be communicated in the filing letter.
    2. The options for communicating filing issues are:
      • If the issues are identified in time for the issuance of the filing letter, they should be included in the filing letter.
      • If issues are identified, but wording cannot be developed by the date of filing letter issuance, they must be communicated by letter, facsimile or secure email to the applicant no later than 14 calendar days after the 60 day filing date.
      • If no issues are identified during the filing review, that assessment must be stated in the filing letter.

      Review Committee Chair:

      • Schedule the filing meeting
      • Conveys the filing information, including deficiencies found, to the RPM for inclusion in the filing letter.
      • If the review committee determines the submission is a Refusal to File (RTF), in accordance with SOPP 8404: Refusal to File Procedures for Biologics License Applications, the chair is responsible for working with the Office Director and the Associate Director for Review Management prior to notifying the applicant.

      Regulatory Project Manager (RPM):

      • Ensures the filing decision is documented in the administrative file
      • Uses the appropriate letter template for the filing/filing issues letter found on CBER's Intranet web page
      • Ensures all communications are entered into the appropriate regulatory database and imported into the Electronic Document Room (EDR)
      • Ensures a letter is sent to the applicant

    1. Effective Date

      August 4, 2010
    2. References

      A.  Web links to the references below can be found in the list following the
           History Table

           Prescription Drug User Fee Act (PDUFA)
           PDUFA III Reauthorization Performance Goals and Procedures
           PDUFA IV Reauthorization Performance Goals and Procedures
           Good Review Management Principles for PDUFA Products (effective 4/11/2005)

    1. History
    1. Written/RevisedApprovedApproval DateVersion NumberComment
      Linda Dixon, BPS, RMCCRobert Yetter, PhDJuly 29, 20102Revised to include new PDUFA information
      Leonard Wilson, Sharon Risso, RMCCRobert Yetter, PhDMay 20, 20031Original