The Office of Pharmaceutical Quality (OPQ) today published a Manual of Policy and Procedures (MaPP) document titled Requests for Expedited Review of New Drug Application and Biologics License Application Prior Approval Supplements Submitted for Chemistry, Manufacturing, and Controls Changes (here) for new drug applications and biologic license application holder that submit a prior approval supplement and seek expediated review.  The document pretty much tracks the policy and process for qualifying for expedited review of PAS supplements for generic applicants.

Expedited review means that the Agency will attempt to beat PDUFA goal dates for review of the supplemental applications that meet the criteria outlined in the MaPP, but FDA notes that an expedited review does not change the PDUFA goal dates for the supplement. All expedited review requests will be evaluated on a case-by-case basis.  No grants of expedited review will be permitted to correct or change a facility that is under an Official Action Indicated designation, unless FDA determines that such action is warranted to address a public health concern.

The MaPP outlines expedited review if the PAS meets one of the following categories

  • Drug Shortages
  • Special Review Programs (like PEPFAR)
  • Public Health Emergencies
  • Certain Government Purchasing Programs
  • Statutory or Regulatory Mandates
  • Extraordinary Hardship on the Applicant (e.g., unanticipated supply stoppage of API, explosion in a plant – things generally outside of the applicant’s control)

The MaPP explains how the OPQ internally will handle such requests.