The Brilinta Resubmission Journey: From FDA CRL to Approval
Hello Regulatory Scientists, Today, let’s delve into the journey of Brilinta (ticagrelor) from receiving an FDA Complete Response Letter (CRL) to achieving approval. Understanding this case provides valuable insights and lessons that can guide companies developing new drugs today. Regulatory History and Initial Submission Drug: Brilinta (ticagrelor) Mechanism of Action: P2Y12 receptor antagonist, which inhibits […]
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 […]