The Zepatier Resubmission Journey: From FDA CRL to Approval

Hello Regulatory Scientists, Today, let’s explore the journey of Zepatier (elbasvir/grazoprevir) 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: Zepatier (elbasvir/grazoprevir) Mechanism of Action: NS5A inhibitor (elbasvir) and NS3/4A protease […]
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 […]
Surviving an FDA Complete Response Letter: Strategies for Success

Dear Regulatory Scientists, Receiving an FDA Complete Response Letter (CRL) after submitting a New Drug Application (NDA) or Biologics License Application (BLA) can feel like a major setback. However, with the right approach, this feedback can be a springboard to ultimate approval. Let’s dive into the immediate actions to take, how to convert a CRL […]
Navigating FDA Accelerated Approval Pathways: A Story of Speeding to Success with Fast Track, Breakthrough Therapy and Priority Review Desigations

Hello Regulatory Scientists, Let’s take a journey through the world of Accelerated Approval Pathways with Dr. Mike, a passionate regulatory scientist, determined to get his groundbreaking therapy to patients as quickly as possible. In this story, we’ll explore how Dr. Mike leverages Fast Track, Breakthrough Therapy, and Priority Review designations to speed up the approval […]