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%.