FDA rejection letters will be released soon after issuance, enhancing transparency in the drug review process.
• FDA to release rejection letters soon after issuance.
• Includes 89 letters from 2024 and 2025.
• Aims to enhance transparency in drug reviews.
The U.S. Food and Drug Administration (FDA) has announced a significant policy change aimed at increasing transparency in the drug review process. The agency will now release rejection letters, known as complete response letters (CRLs), shortly after they are provided to drugmakers. This move is seen as a victory for those advocating for more openness in the regulatory process. The FDA has already made public 89 CRLs from 2024 and 2025, which were previously undisclosed. These include letters sent to companies such as Replimmune, Capricor Therapeutics, Stealth BioTherapeutics, and Ultragenyx. Read more about this development.
Why it matters
Transparency in the drug approval process is crucial for maintaining public trust and ensuring accountability. By releasing these rejection letters, the FDA provides insights into the reasons behind drug rejections, which can help companies improve future submissions. Moreover, this move aligns with the agency’s broader efforts to enhance transparency and communication with stakeholders.
What’s next
The FDA’s decision to release CRLs is expected to set a precedent for future regulatory practices. Drugmakers will need to adapt to this new level of transparency, which may influence how they approach the submission process. As the FDA continues to refine its policies, stakeholders will be watching closely to see how this impacts drug development and approval timelines. For further insights into regulatory changes, visit our Regulatory & Approvals section.