NDA/BLA filing to FDA approval times for new drugs in select disease areas 2011-2020

Published by
Matej Mikulic,
Jun 3, 2022
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

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Release date

February 2021

Region

United States

Survey time period

January 1, 2011, to November 30, 2020

Supplementary notes

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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