News tagged with fda

Study examines gap in federal oversight of clinical trials

An analysis of nearly 24,000 active human research clinical trials found that between 5 percent and 16 percent fall into a regulatory gap and are not covered by two major federal regulations, according to a study in the March ...

Mar 04, 2014
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Common sense, moderation are key on food safety issues

There is often debate over whether or not certain household and food-related products are safe for consumer use or consumption. The controversy often causes media hype that can scare consumers into avoiding common and useful ...

Feb 28, 2014
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Republicans blast FDA monitoring of whistleblowers

(AP)—Republicans are blasting the Food and Drug Administration for secretly monitoring the emails of agency scientists who went public with allegations that they were pressured to approve certain medical devices.

Feb 26, 2014
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Myalept approved for rare fat tissue disorder

(HealthDay)—Myalept (metreleptin for injection) has been approved by the U.S. Food and Drug Administration to treat complications of leptin deficiency for people with the congenital or acquired generalized forms of lipodystrophy.

Feb 25, 2014
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US looks to reboot nonprescription drug system

The U.S. Food and Drug Administration is seeking to revamp its system for regulating hundreds of over-the-counter drugs, saying the decades-old process is not flexible enough to keep pace with modern medical developments.

Feb 21, 2014
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Vimizim approved for rare childhood disorder

(HealthDay)—Vimizim (elosulfase alfa) has been approved by the U.S. Food and Drug Administration to treat a rare childhood disorder called Mucopolysaccharidosis Type IVA, also known as Morquio A syndrome.

Feb 17, 2014
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