Manual of Standard Operating Procedures and Policies

Regulatory - Licensing

Filing Action: Communication Options

SOPP 8401.3

Version #1

May 11, 2003
  1. Purpose
    2.

    The purpose of this document is to describe the communication options for informing an applicant of issues identified during the filing review.

  2. Background
    3.

    When an application or a supplement is submitted, it is reviewed according to Center procedures (SOPP 8404) 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 (PDUFA III), contains new agreements between FDA and applicants, that at the completion of the filing review for biologics license applications, new drug applications, and efficacy supplements to either, 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 acknowledges 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 later be found to not to be a deficiency 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.

  3. Policy
    4.

    It is CBER policy that

    • 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;
    • CBER's performance in meeting the 74-day goal for communication of filing issues will be tracked and reported in the agency's annual report on PDUFA performance.

  4. Responsibilities and Procedures
    5.

    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. Use the Filing Letter template.
    • 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. Use the Filing Issues Letter, facsimile or secure email template.
    • If no issues are identified during the filing review, that finding must be stated in the filing letter.

  5. Effective Date
    6.

    May 11, 2003

  6. References
    7.

    PDUFA III Reauthorization Performance Goals and Procedures

  7. History
    8.

    Written/Revised Approved Approval Date Version Number Comment
    Leonard Wilson, Sharon Risso, RMCC Robert Yetter, PhD May 20, 2003 1 Original

 
Updated: June 3, 2003