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 ...

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