The Farxiga Resubmission Journey: Turning an FDA CRL into Success
Hello Regulatory Scientists, Today, let’s explore the journey of Farxiga (dapagliflozin) from receiving an FDA Complete Response Letter (CRL) to achieving approval. This case provides invaluable insights and lessons that can guide companies developing new drugs today. Regulatory History and Initial Submission Drug: Farxiga (dapagliflozin) Mechanism of Action: Sodium-glucose co-transporter 2 (SGLT2) inhibitor Indication: Type […]
Turning Setbacks into Success: The Eylea Resubmission Journey
Hello Regulatory Scientists, Let’s delve into the journey of Eylea (aflibercept) from receiving an FDA Complete Response Letter (CRL) to its eventual approval. Understanding this case provides valuable insights and lessons for those developing new drugs today. Regulatory History and Initial Submission Drug: Eylea (aflibercept) Mechanism of Action: Vascular Endothelial Growth Factor (VEGF) inhibitor Indication: […]
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 […]
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 […]
Unveiling the Potential of Cell and Gene Therapy in Modern Healthcare
Introduction: In the ever-evolving landscape of healthcare, two essential components take center stage—Drugs and Biologics, with Cell and Gene Therapy at the forefront. These remarkable advancements are not just therapeutic agents; they represent the cutting edge of medical science, offering innovative solutions to a myriad of health challenges. Join us on a journey as […]