The US Food and Drug Administration (FDA) on Monday issued a statement explaining how the agency can facilitate the development of investigational products to diagnose, treat and prevent emerging ...

The FDA released updated guidance on May 29, 2026, formalizing expectations for human factors information in medical device ...

Top officials at the US Food and Drug Administration (FDA) say the agency is developing a new, less formal, way for industry to request input on how combination products will be regulated. Combination ...

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 ...

The U.S. Food and Drug Administration (FDA) has been ahead of the curve for a number of years on emerging issues and opportunities for the agency and regulated industry arising from the advent and ...

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 ...

The U.S. Food and Drug Administration has launched a project to overhaul its application development process to provide management with a view into the agency’s IT projects. The 12-month project, ...

The U.S. Food and Drug Administration (FDA) recently issued three draft guidances concerning development of cell and gene therapy (CGT) products. The guidances provide advice concerning qualifying ...

Dthera ™ Sciences, the leading digital therapeutic company focusing on the elderly and individuals with neurodegenerative diseases, announced today that the U.S. Food and Drug Administration (FDA) has ...

“Cybersecurity is a really important part of your system, and you need to make sure that it's part of your thought process from day one, when you're designing and architecting your device, all the way ...