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# Bioequivalence Studies During Covid-19
- URL: https://www.fdaweb.com/bioequivalence-studies-during-covid-19/
- Published: 2020-04-28T12:00:00.000Z
- Updated: 2026-09-14T16:12:47.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146673

FDA says it is aware that the Covid-19 pandemic may affect the conduct of bioequivalence studies intended for submission in ANDAs. “For example,” an online [statement](https://www.fda.gov/drugs/coronavirus-covid-19-drugs/bioequivalence-studies-submission-andas-during-covid-19-pandemic?ref=fdaweb.com) says, “challenges may arise from quarantines, site closures, travel limitations, interruptions to the supply chain for the proposed generic product or the reference-listed drug product, or other considerations if site personnel or study subjects become infected with Covid-19.”

The statement says that ANDA applicants should prioritize the protection of study participants as they consider restarting bioequivalence studies. It also has information on submitted ANDAs and for potential applicants.