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Tag Archives: FDA

D.C. court blocks graphic FDA cigarette warnings

A federal district court in Washington has blocked a federal rule requiring graphic warnings to be placed on all cigarette packaging and advertising in the United States. The court issued a preliminary injunction in favor of tobacco companies who sued ...

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FDA approves 35 new drugs

The U.S. Food and Drug Administration announced it approved 35 significant new medicines for the fiscal year ending Sept 30. The FDA said the number of new drugs approved is among the highest in the past decade, surpassed only by ...

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Obama to order FDA to help reduce drug shortages

WASHINGTON (AP) — President Barack Obama is directing the Food and Drug Administration to take steps to reduce drug shortages, an escalating problem that has endangered patients and raised the possibility of price gouging. Patient deaths have been blamed on ...

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Generic drug labels concern consumers

In most cases, generic drugs can be as good as brand name drugs, but consumer groups, attorneys and some U.S. Supreme Court justices fear their warning labels are not. That’s because Federal Drug Administration rules allow brand name drug manufacturers ...

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Guidance on benefit-risk medical device calls

For the first time, the Food and Drug Administration has issued guidance on the benefit-risk determinations involved in premarket review of high-risk medical devices.

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Rule changes expand FDA’s legal authority

The Food and Drug Administration recently announced its first two rule changes pursuant to the authority granted the agency by the FDA Food Safety Modernization Act signed by President Barack Obama in January.

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Technical glitch threatens food safety bill

Hours after the Senate passed the FDA Food Safety Modernization Act, which would overhaul the nation’s food safety system in response to a rash of recalls and food borne illnesses, a technical problem in the text of the bill threatened its chances of becoming law.

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Egg recall spurs food safety debate

After an Iowa egg producer and the Food and Drug Administration announced the nationwide recall of more than 500 million shell eggs in connection with a salmonella outbreak that has sickened more than 1,000 people, lawmakers are calling for laws to boost food safety procedures.

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