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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