Center for Drug Evaluation and Research

Current Status and Future Directions: The Application of Artificial Intelligence/Machine Learning for Precision Medicine

Kunal Naik, Rahul K. Goyal, Luca Foschini et al.

2023 · 54 Zit.

AI in medical physics: guidelines for publication

Issam El Naqa, John M. Boone, Stanley Benedict et al.

2021 · 43 Zit.

Measurement and Mitigation of Bias in Artificial Intelligence: A Narrative Literature Review for Regulatory Science

Magnus Gray, Ravi K. Samala, Qi Liu et al.

2023 · 26 Zit.

Artificial Intelligence in Cardiovascular Clinical Trials

Jonathan W. Cunningham, William T. Abraham, Ankeet S. Bhatt et al.

2024 · 24 Zit.

Harnessing large language models’ zero-shot and few-shot learning capabilities for regulatory research

Hamed Meshkin, Joel Zirkle, Ghazal Arabidarrehdor et al.

2024 · 16 Zit.

Report of National Brain Tumor Society roundtable workshop on innovating brain tumor clinical trials: building on lessons learned from COVID-19 experience

Eudocia Q. Lee, Wendy Selig, Clair Meehan et al.

2021 · 14 Zit.

Large Language Models and Their Applications in Drug Discovery and Development: A Primer

James Lu, Keunwoo Choi, Maksim Eremeev et al.

2025 · 14 Zit.

Artificial Intelligence/Machine Learning: The New Frontier of Clinical Pharmacology and Precision Medicine

Qi Liu, Amita Joshi, Joseph F. Standing et al.

2024 · 14 Zit.

A framework enabling LLMs into regulatory environment for transparency and trustworthiness and its application to drug labeling document

Leihong Wu, Joshua Xu, Shraddha Thakkar et al.

2024 · 11 Zit.

Artificial Intelligence in <i>Clinical and Translational Science</i> : From Bench Insights to Bedside Impact

Mohamed H. Shahin, Qi Liu

2025 · 3 Zit.

FDA Perspective on the Importance of Digital Health Technologies in Clinical Trials

Elizabeth Kunkoski, Anindita Saha, Man Hei Marcus Kam

2025 · 2 Zit.

Public feedback to FDA on regulatory considerations for AI in drug manufacturing

Jayanti Das, Thomas O’Connor, Adam C. Fisher et al.

2025 · 1 Zit.

Methodological and regulatory considerations for causal AI in drug development

Hana Lee, Sky Qiu, Spencer R. Haupert et al.

2026 · 0 Zit.

Key Variables Ascertainment and Validation in RW Setting

Sai Dharmarajan, Tae Hyun Jung

2023 · 0 Zit.

Applications of artificial intelligence for real-world evidence generation: a protocol for a living scoping review

Theodora Oikonomidi, Hanaya Raad, John Diaz‐Decaro et al.

2026 · 0 Zit.