Tag Archives: Margaret Hamburg

Docs to FDA: Biosimilars should have different names than branded drugs

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Yesterday, Fierce Biotech highlighted a letter written by more than 10 medical associations and 20 individual specialists to FDA Commissioner Margaret Hamburg saying that biosimilars “must have distinguishable nonproprietary names. The FDA drafted a set of rules for biosimilars in 2012, sparking a debate on whether those drugs should carry the same generic names as the originator products. Now, some doctors are weighing in on the issue, urging the FDA to require biosimilars to have distinguishable names. The physicians argued that using different Read More >

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“No Need to Label GMOs” Says FDA

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The Nation’s Leading Regulatory Body on Food Safety Reaffirms Safety of GMOs On March 28, 2014, the Food and Drug Administration Commissioner Margaret Hamburg testified to the House Appropriations Committee on the FDA’s 2015 budget request. In a line of questioning, she was asked about the labeling of GMOs. The Hill’s Benjamin Goad tracked her response reaffirming that the FDA will not label GM foods. “Margaret Hamburg told lawmakers this week that the agency remains Read More >

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