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 ...

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Please provide your email address to receive an email when new articles are posted on . Among patients with Crohn’s disease, combination testing of the endoscopic healing index and anti-tumor necrosis ...