Breakthrough Designations

Breakthrough status was introduced in the 2012 FDA Safety and Innovation Act to expedite development and review of products for serious medical needs when preliminary evidence indicates that the agent may provide substantial improvement over existing therapies on one or more clinically significant endpoints. Updated weekly.

Use the search box to filter the chart data. Click on column headers to sort the information. Use the tabs below to switch between the BTD list and FDA’s most recent tally of requests and awards.

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