Center for Biologics Evaluation and Research

Real-world data for 21^st-century medicine: The clinical and translational science awards program perspective

Pablo Cure, Sanae ElShourbagy Ferreira, Joshua P. Fessel et al.

2023 · 3 Zit.

Development of Interoperable Computable Phenotype Algorithms for Adverse Events of Special Interest to Be Used for Biologics Safety Surveillance: Validation Study

Ashley A Holdefer, Jeno Pizarro, Patrick Saunders‐Hastings et al.

2024 · 1 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.