TITLE:
Frameworks for the Future: Implementing FDA Guidance on Artificial Intelligence in Biopharma
AUTHORS:
Kishore Raju Vatsavai, Jayaram Kamma, Anil Kumar Ramgiri, Kishore Kumar Hotha
KEYWORDS:
Artificial intelligence (AI), Machine Learning (ML), Drug Development, FDA Guidance, Biopharmaceutical Regulation, Clinical Trials, Pharmaceutical Manufacturing, Pharmacovigilance
JOURNAL NAME:
American Journal of Analytical Chemistry,
Vol.17 No.3,
March
30,
2026
ABSTRACT: Artificial Intelligence (AI) is transforming the pharmaceutical industry, from early drug discovery to post-market surveillance. The recent Food and Drug Administration (FDA) draft guidance “Artificial Intelligence in Drug and Biological Product Development”—outlines regulatory expectations for AI/ML in drug development, emphasizing transparency, reliability, and human oversight. This article compiles insights from regulatory discussions, technical literature, and real-world applications to examine how AI speeds up innovation while introducing new challenges. It highlights key opportunities in R&D, clinical development, manufacturing, and quality assurance, and discusses the future path for pharma and biotech organizations striving to responsibly incorporate AI into their operations.