FDA Decision Alerts

Our FDA Decision Alerts summarize examples in which RWE was included in the submission package for new drugs and biologics. We’ll share updates to this library as the FDA makes approval documents available—and we invite you to subscribe to these alerts below.

April 21, 2020

CBER-Approved BLA for ZOLGENSMA (onasemnogene abeparvovec-xioi)

Nick Honig, Christina Purpura, and Liz Garry
April 20, 2020
April 20, 2020
April 20, 2020
April 20, 2020

CDER-Approved NDA for PRETOMANID TABLETS

Christina Purpura and Liz Garry
April 20, 2020

CDER-Approved NDA for EGATEN™ (triclabendazole)

Christina Purpura and Tony Louder
April 20, 2020

The Evidence Digest and FDA Decision Alerts

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