More NDAs to become BLAs following FDA definition change
A list of approved biologics that are set to go from being regarded as New Drug Applications (NDAs) to Biologics License Applications (BLAs) has been updated.
According to the latest update from the US Food and Drug Administration (FDA), four more approved drugs are on the preliminary list of products that will be deemed to be BLAs from March 23 of this year.
Of these four new drugs, three reflect a change to the statutory definition of biological product made by the Further Consolidated Appropriations Act, 2020, which was enacted on December 20, 2019.
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