The Zolgensma Resubmission Journey: From FDA CRL to Approval
Hello Regulatory Scientists, Today, let’s delve into the journey of Zolgensma (onasemnogene abeparvovec) from receiving an FDA Complete Response Letter (CRL) to achieving approval. This case study provides valuable insights and lessons that can guide companies developing new drugs today. Regulatory History and Initial Submission Drug: Zolgensma (onasemnogene abeparvovec) Mechanism of Action: Gene therapy that delivers […]