Device and pharmaceutical manufacturers must understand the differences in scientific expectations and cultural environments between CDRH and CDER to obtain FDA approval of drug-device combination ...

Determining whether you have a cold, the flu or Covid-19 might be getting a little easier soon. On Friday, the U.S. Food and Drug Administration authorized the first over-the-counter combination test ...

The past two years have seen relatively quiet flu seasons — a welcome development as hospitals and the public health system focused on managing waves of COVID-19. But experts are expecting flu to make ...

Researchers at the National Institute of Standards and Technology have released an updated version of a computer system testing tool that can cut costs by more efficiently finding flaws. A tutorial on ...

Many regulatory considerations may be unfamiliar to manufacturers pursuing market approval of combination products. Understanding and planning for these considerations can significantly affect FDA ...