The Rukobia Resubmission Journey: From FDA CRL to Approval
Hello Regulatory Scientists, Today, let’s explore the journey of Rukobia (fostemsavir) 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: Rukobia (fostemsavir) Mechanism of Action: Attachment inhibitor that prevents the HIV-1 virus […]
The Kalydeco Resubmission Journey: From FDA CRL to Approval
Hello Regulatory Scientists, Today, let’s dive into the journey of Kalydeco (ivacaftor) 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: Kalydeco (ivacaftor) Mechanism of Action: CFTR potentiator, which helps to […]