BioCentury
DATA GRAPHICS | Regulation

Most accelerated approvals gain full approval within five years: Data Byte 

An analysis from BioCentury’s 2021  Back to School package

September 8, 2021 11:41 PM UTC

Contrary to the view that companies often do not attend to their postmarket commitments in a timely manner after an accelerated approval, an analysis published as part of BioCentury’s annual Back to School project found the median time from accelerated to full approval was 3.2 years, with 75% of the approvals converted in fewer than five years. 

Moreover, only a small fraction of accelerated approvals remain pending after four years. Among accelerated approvals granted before 2017, 87% have either been converted to full approval or withdrawn...