RegBlog

RegBlog

FDA

Inflating Civil Penalties

Apr 2, 2014 News

FDA adjusts maximum civil money penalties to account for inflation.

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What is the Future for Genetic Testing and Personalized Medicine?

Feb 6, 2014 Analysis

FDA declares personalized medicine “has clearly arrived.”

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A New Tax-and-Spend Strategy to Fight Obesity

Jan 6, 2014 Analysis

Scholar proposes a manufacturers’ excise tax to fund obesity-prevention efforts.

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FDA to Require Medical Device ID Numbers

Dec 12, 2013 News

New agency rule designed to help identify faulty medical devices.

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Learning from the FDA’s Plan B Fiasco

Dec 11, 2013 Opinion

Plan B episode calls for reconsidering the scope of judicial review and the role of politics in rulemaking.

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The FDA Trans Fats Ban and the Goal of Informed Consumers

Nov 21, 2013 News

FDA seeks comment on its determination trans fats are unsafe and should be banned.

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FDA Moves to Address Drug Shortages

Nov 19, 2013 News

Agency hopes a strategic plan and proposed rule will protect patients from delayed treatment.

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House Bill Would Limit FDA Oversight of Health Apps

Nov 18, 2013 Analysis

Supporters of legislation argue FDA will not cabin its regulatory power on its own.

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Indian Supreme Court Demands Regulation of Clinical Trials

Oct 24, 2013 Analysis

Court asks government to protect vulnerable people from poorly-run trials.

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Hold the Phone: FDA to Regulate Smartphone Health Apps?

Sep 25, 2013 Analysis

As mobile health industry grows, regulation looms.

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