Reporter, Washington, DC
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Mar 13, 2014

U.S. still weighing if genetically altered fish is safe: FDA chief

WASHINGTON (Reuters) – The Food and Drug Administration is still considering whether a proposed genetically engineered fish is safe for consumers, the agency’s top official said on Thursday.

FDA Commissioner Margaret Hamburg said it was examining as many as 35,000 comments about the application on the salmon by Boston-based AquaBounty Technologies Inc, which applied for approval in the mid-1990s.

Mar 13, 2014

FDA chief defends new pain drug despite worries about abuse

WASHINGTON (Reuters) – The head of the Food and Drug Administration on Thursday defended the agency’s approval of Zohydro, a powerful prescription opioid made by Zogenix Inc, saying it offers a “unique” option to treat pain despite concerns about potential abuse.

The FDA’s approval of the drug has drawn a flood of criticism, including protests from the attorneys general of 28 states as well as dozens of groups representing doctors and addiction treatment specialists who are concerned that Zohydro will set off a wave of addiction similar to problems with the original form of OxyContin, another opioid.

Mar 13, 2014

U.S. FDA chief defends approval of Zogenix’s ‘unique’ pain drug Zohydro

WASHINGTON, March 13 (Reuters) – U.S. Food and Drug
Administration Commissioner Margaret Hamburg on Thursday
defended the agency’s approval of Zogenix Inc’s
Zohydro, saying the powerful prescription opioid offered a
unique option to help treat pain.

Law enforcement officials, doctors and addiction treatment
specialists are concerned that Zohydro would set off a wave of
addiction similar to problems with the original form of
OxyContin.

Mar 13, 2014
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