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
If Mylan wants to improve access to its emergency allergy treatment EpiPen, then the company should lower the price of the drug, instead of marketing a generic version, members of the House Committee on Oversight and Government Reform said. Read More
The FDA is providing guidance for devicemakers that want to coordinate development of antimicrobial susceptibility tests with sponsors developing antimicrobial drugs. Read More
The FDA issued a final order on Sept. 21 that classified magnetic surgical instrument systems as Class II devices with special controls. Read More
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