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The percentage of FDA-approved clinical trials that include patient-reported health outcomes has reached 80 percent, CDRH Director Jeff Shuren said at the FDA/CMS Summit. Read More
No documentation was found indicating that the firm followed up to obtain missing or additional information or issued a device recall that would have aided in the investigation. Read More
FDA inspection reports consistently show that the corrective and preventive action process is the biggest inspection problem for medical device facilities. And those who have to implement CAPAs have plenty of questions about how best to manage them. Read More