Posts Tagged ‘IOM’

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January 14th, 2015

Hidden Clinical Trial Data: A Dam About to Burst

Two important new developments may mean that many more researchers will soon be able to access and analyze data from many more clinical trials. In recent years, in response to troubling and far-reaching questions about the availability and reliability of clinical trial data, reformers have called for new policies that would require drug companies and other […]


March 11th, 2013

Devices vs. Drugs: A Distinction Without a Difference? Blogging from ACC.13

How are devices regulated? Due to some quirks, the tail now wags the dog.


July 29th, 2011

Controversial IOM Report Highly Critical of 510(k) Process

The Institute of Medicine (IOM) has released a report highly critical of the FDA’s 510(k) medical device clearance process and called on the FDA to develop “a new framework that used both premarket clearance and improved postmarket surveillance of device performance to provide reasonable assurance of the safety and effectiveness of Class II devices.” The […]


June 22nd, 2011

JAMA: Skeptical Perspectives on Consumer Cardiac Tests and Vitamin D

Two commentaries published in JAMA offer skeptical perspectives on the roles of direct-to-consumer (DTC) cardiac tests and vitamin D in cardiovascular health. In the first commentary, Kimberly Lovett and Bryan Liang write that DTC screening tests “likely pose more risk than benefit to patients,” and point out that for companies selling these tests there is no requirement […]