Will a New FDA User Fee Discourage Medical Device Innovation?

Bloomberg June 12, 2017: The NCHR is warning that a new FDA user fee could make the de novo pathway more appealing by speeding up device reviews, but at the cost of safety. NCHR says this fast-track process often skips clinical trials and lacks solid scientific proof, putting patients at risk.

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FDA Questions Effect of Abuse-Deterrent Opioids

June 13 2017: The NCHR cautions that opioids labeled as “abuse-deterrent” might not actually stop misuse and can still be abused, giving a false sense of safety. They urge the FDA to ensure that such labels accurately reflect the risks to protect patients from harm.

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Amy Reed, MD, Morcellator Opponent, Dies of Uterine Cancer

Medscape, May 25 2017: Dr. Amy Reed, a mother of six and physician, died at 44 after her cancer spread during a routine surgery using a power morcellator. She and her husband led a campaign that prompted the FDA to warn against the device’s use, aiming to protect other women from similar harm.

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Trump budget would cut $636 billion from HHS agencies

The Trump administration’s proposed budget includes a $636 billion reduction to the Department of Health and Human Services, prompting worries about potential impacts on healthcare services, medical research funding, and essential public health programs that many Americans rely on.

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