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The FDA is providing guidance for devicemakers that want to coordinate development of antimicrobial susceptibility tests with sponsors developing antimicrobial drugs. Read More
Patients will play a bigger role in device assessments, and more data will come directly from patients in the future, FDA Commissioner Robert Califf told devicemakers. Read More
The FDA and the medical device industry have agreed on the terms for a new medical device reauthorization package that would allow the agency to collect $999.5 million in user fees over the next five years. Read More