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 […]
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: […]
What to Do After Your First CRL from the FDA: A Story of Turning Setbacks into Success
Introduction Imagine you’re a regulatory scientist at a pharmaceutical company. Your team has worked tirelessly for years, conducting clinical trials, collecting data, and finally submitting your New Drug Application (NDA) to the FDA. The anticipation builds as you await their decision, only to receive a Complete Response Letter (CRL). It feels like a punch to […]
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 […]
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 […]