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Accelerated Approval Drugs and Devices Often Fall Short of FDA Standards

FDA’s Accelerated Approval program was intended to allow drugs and medical devices that treat serious conditions to be approved earlier...

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Lawmakers Consider Proposal to Delay Reporting of Medical Device Malfunctions

Despite the fact that medical device malfunctions often lead to severe patient injury or even death, the U.S. Food and...

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FDA: Teething Tablets Potentially Connected to Death of 10 Children

Homeopathic teething tablets have been linked to the deaths of 10 children, and 400 adverse reports concerning the tablets have...

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GI Bleeding Risk Higher in Pradaxa Users Per New Data

According to Medscape, the FDA announced on May 13 that based on the results of a study of 134,000 Medicare...

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Mexican Antimicrobial Products Not Yet Safe

According to the FDA, several companies are marketing products that look like antimicrobial products available in Mexico.  Because of this,...

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