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Frameworks for the Future: Implementing FDA Guidance on Artificial Intelligence in Biopharma

¹ Veranova, Devens, USA
² Lupin, Somerset, USA
³ Appco Pharma LLC, New Jersey, USA
⁴ Dr. Hotha’s Life Sciences LLC, Ayer, USA

American Journal of Analytical Chemistry·Volume 17 (2026)·Pages 45–60·Published 30 March 2026·DOI10.4236/ajac.2026.173005

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 The recent Food and Drug Administration (FDA) draft guidance “Artificial Intelligence in Drug and Biological Product Development”—outlines regulatory expectations for AI/ML in drug development, emphasizing transparency,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.

KeywordsArtificial intelligence (AI)Machine Learning (ML)Drug DevelopmentFDA GuidanceBiopharmaceutical RegulationClinical TrialsPharmaceutical ManufacturingPharmacovigilance

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Frameworks for the Future: Implementing FDA Guidance on Artificial Intelligence in Biopharma

Abstract

References (29)