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 ...

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 ...

In a landmark decision poised to revolutionize drug development, the U.S. Food and Drug Administration (FDA) has announced a new initiative to significantly reduce, refine, and replace animal testing ...

The Food and Drug Administration (FDA) published a pair of discussion papers this week in an effort to outline areas artificial intelligence and machine learning may help in manufacturing ...

There has been much discussion recently about how artificial intelligence and machine learning (AI/ML) will revolutionize pharmaceutical research. Substantial progress has been made in the discovery ...

Recognizing the increased use of artificial intelligence in the development of new therapies, the U.S. FDA on Monday released separate draft guidance on the use of the technology in the development of ...

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...