Only company-sponsored, FDA registration-enabling development
programs were included in this analysis. Investigator-sponsored studies and combinations with other
investigational drugs were excluded.
NDA - New Drug Application.
BLA - Biologic License Application.
Citation formats
NDA/BLA filing to FDA approval times for new drugs in select disease areas 2011-2020
This statistic shows the time from filing to approval for NDA/BLA filings for new drugs in the U.S., in the period from , to **, by disease area. It was found that new drugs in endocrine and psychiatry took the longest average time to be approved, with an average of *** years.
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Biotechnology Innovation Organization, & QLS Advisors, & Pharma Intelligence. (February 26, 2021). Time from NDA/BLA filings for new drugs to FDA approval in select disease areas in the U.S. between 2011 and 2020 [Graph]. In ÌÇÐÄÆƽâ°æ. Retrieved July 29, 2026, from /statistics/597817/nda-bla-filing-approval-times-new-drugs-us/
Biotechnology Innovation Organization, und QLS Advisors, und Pharma Intelligence. "Time from NDA/BLA filings for new drugs to FDA approval in select disease areas in the U.S. between 2011 and 2020." Chart. February 26, 2021. ÌÇÐÄÆƽâ°æ. Accessed July 29, 2026. /statistics/597817/nda-bla-filing-approval-times-new-drugs-us/
Biotechnology Innovation Organization, QLS Advisors, Pharma Intelligence. (2021). Time from NDA/BLA filings for new drugs to FDA approval in select disease areas in the U.S. between 2011 and 2020. ÌÇÐÄÆƽâ°æ. ÌÇÐÄÆƽâ°æ Inc.. Accessed: July 29, 2026. /statistics/597817/nda-bla-filing-approval-times-new-drugs-us/
Biotechnology Innovation Organization, and QLS Advisors, and Pharma Intelligence. "Time from Nda/Bla Filings for New Drugs to Fda Approval in Select Disease Areas in The U.S. between 2011 and 2020." ÌÇÐÄÆƽâ°æ, ÌÇÐÄÆƽâ°æ Inc., 26 Feb 2021, /statistics/597817/nda-bla-filing-approval-times-new-drugs-us/
Biotechnology Innovation Organization & QLS Advisors & Pharma Intelligence, Time from NDA/BLA filings for new drugs to FDA approval in select disease areas in the U.S. between 2011 and 2020 ÌÇÐÄÆƽâ°æ, /statistics/597817/nda-bla-filing-approval-times-new-drugs-us/ (last visited July 29, 2026)
Time from NDA/BLA filings for new drugs to FDA approval in select disease areas in the U.S. between 2011 and 2020 [Graph], Biotechnology Innovation Organization, & QLS Advisors, & Pharma Intelligence, February 26, 2021. [Online]. Available: /statistics/597817/nda-bla-filing-approval-times-new-drugs-us/
