New Drug Applications Pile Up With FDA As Pandemic Still Sore Spot For Delayed Inspections

New Drug Applications Pile Up With FDA As Pandemic Still Sore Spot For Delayed Inspections

The FDA continues to face a backlog of drug manufacturing facility inspections. A total of 52 new drug (but no biologics) applications remain delayed due to the backlog from the pandemic. The agency has maintained that it won’t issue a Complete Response Letter (CRL) for a delayed inspection.

  • The number of delayed applications is rising as FDA said in May that 48 new drug applications had been delayed as it could not conduct pre-approval, pre-market, or pre-license inspections as of last March.
  • The agency’s inability to work overseas has also hurt its output well into 2021.
  • Just 37 foreign drug inspections have been conducted between April and September 2021. Before the pandemic, the FDA typically conducted about 1,000 foreign drug inspections per year.
  • The agency has sought to shift to more remote facilities assessments, but the legal definition of an inspection is conducted on-site.
  • In early 2021, the FDA estimated that over 15,000 surveillance inspections throughout the US had been postponed thanks to the pandemic. 
  • The agency predicted completing 14% of those inspections, including 26% of the remaining human and animal medical domestic surveillance inspections. 
  • Related Link: FDA Outlines Plan For Restarting Facility Inspections Halted Due To Pandemic.
  • The agency exceeded that number two-fold. It reported a completion rating of 134%.

Posted In: BriefsBiotechNewsHealth CareFDAGeneral