The Jardiance Resubmission Journey: From FDA CRL to Approval
Hello Regulatory Scientists, Today, let’s explore the journey of Jardiance (empagliflozin) 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: Jardiance (empagliflozin) Mechanism of Action: Sodium-glucose co-transporter 2 (SGLT2) inhibitor, which […]
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 […]
CAR-T Cell Therapy in the FDA Spotlight
CAR-T Cell Therapy in the FDA Spotlight. FDA mandated boxed warnings for CAR-T cell therapies, this followed a 28 November 2023 communication that FDA was “Investigating Serious Risk of T-cell Malignancy Following BCMA-Directed or CD19-Directed Autologous Chimeric Antigen Receptor (CAR) T cell Immunotherapies,” and a July — September 2023 Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event […]