This statistic shows the time from filing to approval for NDA/BLA filings for new drugs in the U.S., in the period from January 1, 2011, to November 30, 2020, 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 1.8 years.
Time from NDA/BLA filings for new drugs to FDA approval in select disease areas in the U.S. between 2011 and 2020
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.
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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 Statista. Retrieved December 30, 2024, from https://www.statista.com/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. Statista. Accessed December 30, 2024. https://www.statista.com/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. Statista. Statista Inc.. Accessed: December 30, 2024. https://www.statista.com/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." Statista, Statista Inc., 26 Feb 2021, https://www.statista.com/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 Statista, https://www.statista.com/statistics/597817/nda-bla-filing-approval-times-new-drugs-us/ (last visited December 30, 2024)
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: https://www.statista.com/statistics/597817/nda-bla-filing-approval-times-new-drugs-us/
