The joint guidance was created to ensure drug developers employ best practices when using AI.

Early in the new year, the US Food and Drug Administration (FDA) released two anticipated draft guidance documents focused on artificial intelligence (AI): Artificial Intelligence-Enabled Device ...

Jan 14 (Reuters) - The U.S. Food and Drug Administration and the European Medicines Agency jointly issued principles for safe ...

On January 6, 2025, the U.S. Food and Drug Administration (FDA) released draft guidance titled Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and ...

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 ...

Recursion Pharmaceuticals leverages AI and machine learning to revolutionize drug discovery, reducing costs and accelerating development, positioning itself as a leader in tech-driven biopharma. The ...

New approach methodologies (NAMs) aim to address the limitations of animal models by assessing drug efficacy and safety in a more ethical, human-relevant way. The term ‘NAMs’ encompasses several ...

Please provide your email address to receive an email when new articles are posted on . The FDA issued draft guidance that would streamline testing of biosimilars. A separate plan would eliminate ...

The FDA has proposed new policies to speed up the development and lower the cost of biosimilar agents for cancer and other serious illnesses. These policies include “major updates to simplify ...

Developing high-quality, safe, and effective drugs is a complex process that requires varied scientific skills and stringent regulatory assessments. Drug development is a process that spans many years ...

Revvity offers comprehensive solutions designed to help accelerate laboratory workflows, assisting researchers meet targets faster and bring new therapies to market sooner. Our integrated approach ...