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# CDER Boosts Alternate Inspection Methods During Pandemic
- URL: https://www.fdaweb.com/cder-boosts-alternate-inspection-methods-during-pandemic/
- Published: 2021-01-27T12:00:00.000Z
- Updated: 2026-09-14T16:44:21.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148533

CDER says the percentage of pre-approval inspections not conducted and other tools and approaches used instead due to the Covid-19 pandemic rose from 48% in the third quarter of Fiscal Year 2020 to 60% in the fourth quarter, which ended 9/30/20\. The Center’s latest [update](https://www.fda.gov/industry/fda-user-fee-programs/cders-work-meet-user-fee-goals-during-pandemic?ref=fdaweb.com) on key metrics related to application review and the pre-approval process during the pandemic says that due to practice constraints such as travel limitations and quarantine and physical distancing requirements or lockdowns, CDER has been relying on inspection alternatives including: 

- reviewing facilities’ compliance history;
- using information shared by trusted foreign regulatory partners through mutual recognition and confidentiality agreements;
- requesting records directly from facilities instead of on-site drug and biological product inspections; and
- sampling drugs at the border.

Charts in the report also show the percentage of applications acted on during the fiscal year by quarter, on or before their user fee goal date, and the number of ANDA originals and ANDA, NDA, and BLA manufacturing supplements approved for drugs and biologics used to treat Covid-19 patients.