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  5. GDUFA II Submission Review
  1. Generic Drug User Fee Amendments

GDUFA II Submission Review

The GDUFA II commitment letter describes a consolidated review goals scheme for all cohorts of abbreviated new drug applications (ANDAs), prior approval supplements (PASs) and amendments. This includes shorter review goals for generic drug submissions that are public health priorities.

The tables below provide information regarding the relevant review goal timeframes for respective submission types under GDUFA II. As outlined in the GDUFA II commitment letter, each review goal timeframe generally applies to 90% of submissions. In addition to the commitment letter, the FDA Reauthorization Act (FDARA) also has statutory provisions regarding submission review goals.

Submission Type Goal

Standard Original ANDAs

Within 10 months of submission date.

Priority Original ANDAs

Within 8 months, provided the applicant, not later than 60 days prior to the submission of an application, provides as required by 21 U.S.C. 355(j)(11):

  • Complete and accurate information regarding facilities involved in manufacturing processes and testing of the drug that is the subject of the application; and
  • The information remains unchanged relative to the date of the submission of the application.*

Within 10 months of submission date if:

  • The applicant does not identify the submission as eligible for prioritization pursuant to FDA’s prioritization criteria, or FDA determines it does not appear to meet the prioritization criteria.
  • The applicant does not pre-submit facility information, or the facility information changes or is found to be incomplete or inaccurate.

Submission Type Goal

Standard Major ANDA Amendments

Within 8 months of submission date if preapproval inspection not required.

 

Within 10 months of submission date if preapproval inspection required.

Priority Major ANDA Amendments

Within 6 months of submission date if preapproval inspection not required.

Within 8 months,provided the applicant, not later than 60 days prior to the submission of an application, provides as required by 21 U.S.C. 355(j)(11):

  • Complete and accurate information regarding facilities involved in manufacturing processes and testing of the drug that is the subject of the application; and
  • The information remains unchanged relative to the date of the submission of the application.*

Within 10 months of submission date if:

  • The applicant does not identify the submission as eligible for prioritization pursuant to FDA’s prioritization criteria, or FDA determines it does not appear to meet the prioritization criteria.
  • When preapproval inspection is required, the applicant does not pre-submit facility information, or the facility information contained in the PFC changes or is found to be incomplete or inaccurate.

Standard and Priority Minor ANDA Amendments

Within 3 months of submission date.

Submission Type Goal

Standard PASs

Within 6 months of submission date if preapproval inspection not required.

Within 10 months of submission date if preapproval inspection required.

Priority PASs

Within 4 months of submission date if preapproval inspection not required.

Within 8 months, provided the applicant, not later than 60 days prior to the submission of an application, provides as required by 21 U.S.C. 355(j)(11):

  • Complete and accurate information regarding facilities involved in manufacturing processes and testing of the drug that is the subject of the application; and
  • The information remains unchanged relative to the date of the submission of the application.*

Within 10 months of submission date if:

  • The applicant does not identify the submission as eligible for prioritization pursuant to FDA’s prioritization criteria, or FDA determines it does not appear to meet the prioritization criteria.
  • When preapproval inspection is required, the applicant does not pre-submit facility information, or the facility information contained in the PFC changes or is found to be incomplete or inaccurate.

Submission Type Goal

Standard PAS Major Amendments

Within 6 months of submission date if preapproval inspection not required.

 

Within 10 months of submission date if preapproval inspection required.

Priority PAS Amendments

Within 4 months of submission date if preapproval inspection not required.

 

Within 8 months, provided the applicant, not later than 60 days prior to the submission of an application, provides as required by 21 U.S.C. 355(j)(11):

  • Complete and accurate information regarding facilities involved in manufacturing processes and testing of the drug that is the subject of the application; and
  • The information remains unchanged relative to the date of the submission of the application.*

 

Within 10 months of submission date if:

  • The applicant does not identify the submission as eligible for prioritization pursuant to FDA’s prioritization criteria, or FDA determines it does not appear to meet the prioritization criteria.
  • When preapproval inspection is required, the applicant does not pre-submit facility information, or the facility information contained in the PFC changes or is found to be incomplete or inaccurate.

Standard and Priority Minor PAS Amendments

Within 3 months of submission date.

Submission Type Goal

Type II Active Pharmaceutical Ingredient (API) DMF

Initial completeness assessments within 60 days of the later of the date of DMF submission or DMF fee payment.

Submission Type Goal

Standard Controlled Correspondence

Within 60 days of submission date.

Complex Controlled Correspondence

Within 120 days of submission date.

GDUFA II also includes commitments regarding applications submitted prior to October 1, 2017:

  • Continue to review and act on ANDAs, ANDA amendments, prior approval supplements (PASs), and PAS amendments submitted prior to October 1, 2017, that have been assigned Generic Drug User Fee Amendments of 2012 (GDUFA I) goal dates pursuant to the GDUFA I review metrics applicable to those submissions.
  • Review and act on 90 percent of ANDAs and ANDA amendments with target action dates (TADs) by the goal date. The TAD for an ANDA or ANDA amendment becomes its GDUFA II goal date.
  • Review and act on 90 percent of ANDAs and ANDA amendments pending FDA as of October 1, 2017, that were not subject to GDUFA I goal dates and either (a) were not previously assigned TADs or (b) were previously assigned TADs that came due prior to October 1, 2017, but remain pending in the same review cycle as of October 1, 2017, by GDUFA II ANDA and ANDA amendment goal dates that FDA will assign on October 1, 2017. No such goal date shall be later than July 31, 2018.

    The GDUFA II goal date for these applications is July 31, 2018; for reporting purposes, if an action is not taken by July 31, 2018, the GDUFA II goal date for that application will be considered missed.  FDA has assigned the GDUFA II goal date of July 31, 2018, consistent with the Commitment Letter, to ensure that GDUFA I ANDAs that did not have goal dates are treated fairly vis-a-vis ANDAs that receive goal dates under GDUFA II, i.e., no later than as if the application/amendment were resubmitted on October 1, 2017.

    In order to help facilitate earlier access to generic drugs, however, FDA intends to act on many of these ANDAs prior July 31, 2018.   We are referring to this earlier date as the “bridging” goal date.  This allows FDA to continue with already commenced assessments, and take actions as soon as possible, while still managing the other GDUFA II goals. Assigning bridging goal dates will also increase transparency and provide predictability, so applicants can anticipate planned FDA actions.

    The ANDA regulatory project manager (RPMs) will email the applicant an assigned bridging goal date.  If you have not received a bridging goal date by December 1, 2017, please contact the application RPM.

  • Review and act on amendments received on or after October 1, 2017, to any ANDAs submitted prior to October 1, 2017, pursuant to the amendment review goals set forth in the GDUFA II commitment letter.

FDA has also posted a video which provides additional information regarding performance goals under GDUFA II:

Video | Transcript | Slides (PDF - 134KB)

* With respect to pre-submission of facility information, FDARA allows a change to be made to such information to exclude a facility that was not used to generate data to meet any application requirements for such submission and that is not the only facility intended to conduct one or more unit operations in commercial production.

**Please refer to the GDUFA II commitment letter for additional details regarding timeframes for unsolicited amendments during or between review cycles.  

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