Continuous process improvement can benefit all aspects of life — from personal New Year’s resolutions to complex drug development. In a world where two-thirds of planned improvement initiatives fail, ...

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 ...

Researchers have applied AI and machine learning to every stage of the drug development process. This includes identifying targets in the body, screening potential candidates, designing drug molecules ...

The U.S. Food and Drug Administration (FDA) announced a new process called “Rare Disease Evidence Principles” (RDEP), under which eligible drugs and biologics for ultra-rare diseases caused by known ...

The potential of using artificial intelligence in drug discovery and development has sparked both excitement and skepticism among scientists, investors, and the general public. Researchers have ...

Duxin Sun receives funding from the NIH, FDA, and pharmaceutical industries including Bristol-Myers Squibb, Celgene Corporation, Aurinia Pharmaceuticals, Abbvie, Nanomedicine Innovation Center.

A key part of consultants’ work is the global harmonization of CMC guidelines. Differences in regulatory requirements across regions can lead to inefficiencies in the drug development process.

Scientists at the University of Cambridge have developed a new way to alter complex drug molecules using light rather than ...

The U.S. Senate has a plan to improve drug development for rare disease patients. The exit of controversial CBER chief Vinay ...

The FDA has granted priority review status for pegcetacoplan (Empaveli) to treat two rare kidney diseases that can lead to kidney failure. Up until now, there hadn’t been any drugs approved ...