Pearl Freier, founder of PRVWatch, recently announced the creation of a new GPT tool designed to provide real-time access and analysis of the U.S. Food and Drug Administration's (FDA) Complete Response Letter (CRL) API. The tool, available via PRVWatch, aims to enhance transparency and accessibility to critical regulatory information for the biotech and pharmaceutical industries.CThe new GPT, dubbed "CRL CHATGPT" on the PRVWatch website, allows users to search, summarize, and download Complete Response Letters directly from the FDA’s openFDA API. This innovative application leverages the FDA's public data, offering a streamlined way to navigate the extensive dataset of official communications issued to drug and biologic sponsors when their applications cannot be approved in their current form.CThis development aligns with the FDA's recent push for greater transparency in its regulatory processes. In September 2025, the FDA announced a significant initiative to release future CRLs promptly after they are issued, alongside publishing a large batch of previously unreleased letters. FDA Commissioner Dr. Marty Makary emphasized this move as embracing "radical transparency," providing invaluable insights to help speed therapies to market and restore public trust.CPearl Freier, with a background spanning healthcare technology, AI, and policy, including experience at the FDA, NIH, and Medtronic, founded PRVWatch to monitor and analyze regulatory developments. Her expertise underpins the creation of tools like the CRL GPT, which translates complex regulatory data into actionable insights for stakeholders.CThe availability of such a tool is expected to significantly benefit drug developers, investors, and researchers by offering clearer insights into the common reasons for non-approvals. By making this information more readily digestible, the PRVWatch GPT could help companies avoid common pitfalls, refine their development strategies, and potentially accelerate the drug approval process, contributing to a more efficient and transparent regulatory landscape.