The Zydelig Resubmission Journey: Navigating the Path to FDA Approval

Hello Regulatory Scientists, Today, let’s explore the journey of Zydelig (idelalisib) from receiving an FDA Complete Response Letter (CRL) to achieving approval. This case studyprovides valuable insights and lessons that can guide companies developing new drugs today. Regulatory History and Initial Submission Drug: Zydelig (idelalisib)Mechanism of Action: PI3K delta inhibitor, which helps to inhibit the […]
The Qsymia Resubmission Journey: Overcoming an FDA Complete Response Letter

Hello Regulatory Scientists, Today, let’s explore the journey of Qsymia (phentermine and topiramate extended-release) from receiving an FDA Complete Response Letter (CRL) to gaining approval. This case offers valuable insights and lessons that can be applied by companies developing new drugs today. Regulatory History and Initial Submission Drug: Qsymia (phentermine and topiramate extended-release) Mechanism of […]