FDA Proposes Allowing Medical Device Makers to Summarize Malfunctions

Star Tribune, February 24, 2018. A Food and Drug Administration (FDA) proposal to let medical device makers summarize complications caused by medical devices instead of filing a report for each incident has kicked off a debate over safety. NCHR and patient and public health advocates say this would keep too many details secret.

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FDA and Opioids: Too Much Regulation or Not Enough?

MedPage Today, January 31, 2018. The FDA is trying to find a streamlined approach to the opioid crisis. Dr. Zuckerman urged the FDA to include education on “abuse deterrent” within its Risk Evaluation and Mitigation Strategies since the term is often misinterpreted to mean the drug is less addictive.

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Big Pharma Greets Hundreds of Ex-Federal Workers at the ‘Revolving Door’

Kaiser Health News, January 25, 2018. A Kaiser Health News analysis shows that hundreds of people have glided through the “revolving door” that connects the drug industry to Capitol Hill and to the Department of Health and Human Services. Experts say the cozy relationships don’t necessarily mean congressional staffers do favors for lobbyists they know, but the access doesn’t hurt.

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The Problem with Medical Device Approval

MedShadow, January 16, 2018. To get FDA approval for a medical device, a company needs to say that its device is “substantially equivalent” to an existing one. Devices might be easily approved without further safety and effectiveness studies.

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