Assessing the Capabilities of ChatGPT-4 in Accurately Responding to Frequently Asked Questions Derived from FDA Regulatory Guidelines: A Detailed Evaluation of Accuracy and Relevance in CMC Applications

Artificial Intelligence (AI) and Machine Learning (ML) are transforming numerous industries, including pharmaceutical industry. Their application promises enhanced efficiency, accuracy, and decision-making in areas such as Drug discovery, Regulatory affairs and Chemistry, Manufacturing, and Controls (CMC). AI and ML are increasingly used to streamline data management, enhance risk management, and automate routine tasks in regulatory contexts. ChatGPT-4, the latest iteration of OpenAI's language model, represents a significant advancement in AI capabilities. It excels in understanding and generating human-like text, maintaining context in conversations, and adapting to specialized domains. This study aims to compare ChatGPT-4's responses with those provided by the United States Food and Drug Administration (FDA) for selected questions from the document "FDA Guideline Changes to an Approved NDA or ANDA: Questions and Answers." The findings will highlight the model's effectiveness in regulatory environments and help evaluate its reliability in CMC applications.