Adverse Events

News & Analysis as of

Federal Preemption and Peer Review - A New Frontier

It’s not often that we get to blog about a new area of federal preemption, but we do so today. This isn’t a big area, otherwise we would have known about it before, but it is pertinent to drug and medical device product...more

Anything in the New Clinical Trial Rules of Interest to Product Liability? Not Really.

An inter-agency taskforce is proposing a comprehensive overhaul of “Federal Policy for the Protection of Human Subjects” in today’s issue of the Federal Register (comments close on 12/7/2015). See 80 Fed. Reg. 53933 (Sept....more

Medical Liability Reform – Iowa’s Communication and Optimal Resolution (Candor) Bill Effective July 1, 2015

On July 1, 2015, the Iowa legislature rolled out what is being heralded as its most significant medical liability reform of the past decade: enabling confidential “open discussions” between health care providers and patients...more

Launch of openFDA Increases Accessibility to Adverse Drug Event Reports

On June 2, 2014, the Food and Drug Administration launched openFDA, a program designed to improve access to publicly available data beginning with adverse event reports. While greater accessibility to adverse event reports...more

Grand Opening of

Information is power, and as of this month, there’s a new power source of information about drug effects. is an initiative of the U.S. Food and Drug Administration to expand access to and use of reports of...more

FDA Launches Huge Online Database of Adverse Events

As part of the Obama administration's effort to make public information more accessible, the FDA launched openFDA on June 2, 2014. This new database makes nearly 4 million pharmaceutical adverse event reports the FDA...more

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