FDA’s ability to conduct on-site inspections has been significantly impacted by the COVID-19 pandemic.  While the FDA is looking and utilizing alternate methods to conduct such inspections when needed, some of the alternate methods are, at least, as time-consuming as actual on-site inspections.  Because of this issue and the Agency’s goal of being transparent, they have issued a guidance document (here ) explaining how review timelines will be established for certain applications needing inspection prior to approval.

The guidance may explain why some complete response letters (CRL) regardless of the nature of the deficiencies are being classified as major amendments subject to a longer goal date/review timeline.  As stated in the guidance if in a CRL the FDA communicates that either of the following apply:

  • Requires an inspection that cannot be conducted in a timely manner because of COVID-19; or
  • Involves the use of time- and resource-intensive alternative tools to assess a facility or BIMO site

“Amendments to original ANDAs and amendments to prior approval supplements to approved ANDAs submitted under section 505(j) of the FD&C Act will be received as a major amendment and will be reviewed per the guidance for industry ANDA Submissions—Amendments to Abbreviated New Drug Applications Under GDUFA (July 2018), regardless of whether the CR letter contains a major deficiency.”

“Resubmissions of original applications and efficacy supplements for NDAs under sections 505(b)(1) and (2) of the FD&C Act and for BLAs under section 351(a) of the PHS Act will be subject to a Class 2 review timeline of 6 months.  This timeline is consistent with existing policies and practices when a facility inspection is required and will also be followed under this temporary policy if FDA uses alternative tools for its facility assessment.”

There will be no changes in the review timelines regardless if FDA conducts an inspection or uses alternate tools to assess the facility for the following:

  • Resubmissions of original applications, supplements with clinical data, and manufacturing supplements for BLAs under section 351(k) of the PHS Act. These submissions will continue to be subject to existing user fee timelines.
    • Resubmitted manufacturing prior approval supplements will be subject to a 4-month timeline.
    • All other resubmitted applications and supplements in this category will be subject to a 6-month timeline.
  • Resubmissions of manufacturing supplements for NDAs under sections 505(b)(1) and (2) of the FD&C Act and for BLAs under section 351(a) of the PHS Act. These submissions will continue to be subject to existing user fee timelines.
    • Resubmitted manufacturing prior approval supplements will be subject to a 4-month timeline.
    • All other resubmitted manufacturing supplements in this category will be subject to a
      6-month timeline.

These revised review timelines will apply throughout the duration of the pandemic.  Please adjust your expectations accordingly.