The US Food and Drug Administration (FDA) recently issued its draft guidance, Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological ...

Oncologic drug development needs to place a greater focus on the patient, according to a commentary in the current issue of the New England Journal of Medicine. Even though the US Food and Drug ...

In a Q&A, an FDA spokesperson discusses efforts to reduce misinformation about biosimilars through education, the agency’s collaboration with global regulators to streamline development, and its work ...

• Existing uses and current efficiencies: Artificial intelligence, including generative AI, is enhancing efficiency and effectiveness in trial design, patient recruitment and drug manufacturing, and ...

Inflation and the Covid-19 pandemic have put pharmaceutical productivity front and center in recent years. Thus, drug companies are under mounting pressure to prove that new treatments are safe and ...