Margaret Hamburg News
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The National Association of Attorneys General has asked the U.S. Food and Drug Administration to place a “black box warning” on labels of the opioid category of prescription-pain relievers to alert pregnant women that use of such drugs may harm infants.
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A federal judge rejected as “frivolous” a government request to delay the effect of his order giving girls including those 16 and younger access to the so-called morning after-pill without a prescription.
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The lobbyist for grocers including Kroger Co. and Safeway Inc. is calling on President Barack Obama to curtail a U.S. health law provision that mandates the companies display the calorie content of all their foods.
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The top U.S. drug regulator asked Congress for more authority over pharmacies following the deadly meningitis outbreak, a request met with resistance by lawmakers who said existing oversight hasn’t been used to the fullest.
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Six months after a U.S. meningitis outbreak that killed 51 people put the spotlight on their industry, specialty pharmacies that mix their own drugs are falling short of federal safety and sanitation requirements.
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Hospital pharmacists are backing a call by the Food and Drug Administration for added regulation of compounding companies after a meningitis outbreak, calling it a “gray area” with serious implications.
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The horse-meat storm that broke over Europe two months ago has been in one respect a tempest in a horseshoe, because it posed no threat to human health. That’s not a minor caveat in an industry where, in the U.S. alone, tainted food kills 3,000 people each year and sickens 48 million.
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U.S. regulators plan to unveil rules for reviewing the first copies of biologic medicines “very soon,” according to Food and Drug Administration Commissioner Margaret Hamburg .
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Energy drinks, which have been linked to deaths and hospitalizations, may boost blood pressure and lead to an erratic heartbeat, a study found.
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Caffeine levels should be reduced in energy drinks because of health risks, particularly to children, doctors wrote the U.S. Food and Drug Administration.
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