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Category: Regulatory Intelligence

The Aliqopa Resubmission Journey: From FDA CRL to Approval 

Relevance for Current Drug Developers For companies developing drugs today, the Aliqopa case underscores the importance of strategic planning and meticulous attention to detail in the regulatory process. Here are some takeaways to help avoid a CRL and achieve first-cycle approval: Thorough Pre-Submission Preparation: Ensure that all aspects of your submission, particularly manufacturing processes and clinical data, meet FDA standards. Proactive Risk Management: Identify and address potential risks early in the development process to prevent issues from arising during FDA review. Engage with the FDA Early and Often: Regular interactions with the FDA can provide valuable guidance and help steer the development process. Utilize Advisory Committees: Seek feedback from advisory committees to validate data and address potential concerns. Invest in Quality Data: Prioritize the collection of high-quality, detailed safety and efficacy data to support the submission. By learning from the Aliqopa resubmission experience, current drug developers can better navigate the regulatory landscape, avoid common pitfalls, and increase the likelihood of a successful first review cycle approval. Stay diligent and strategic, CERES Regulatory Services

Hello Regulatory Scientists,  Today, let’s dive into the journey of Aliqopa (copanlisib) 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: Aliqopa (copanlisib) Mechanism of Action: PI3K inhibitor, which inhibits phosphatidylinositol-3-kinase, a […]

The Opdivo Resubmission Journey: From FDA CRL to Approval

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Hello Regulatory Scientists, Today, let’s explore the journey of Opdivo (nivolumab) 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: Opdivo (nivolumab) Mechanism of Action: PD-1 inhibitor, which helps the immune […]