Saturday, June 9, 2012

FDA delays decision on drug to prevent HIV

The FDA is delaying a decision on whether to approve a drug for preventing infection with HIV, for 3 more months.

FDA delays decision on drug to prevent HIV - The Washington Post:

"In May, a committee of FDA advisers recommended that the agency approve Truvada for HIV prevention in specific high-risk groups, including men who have sex with men and partners of those infected with HIV.

After that meeting, the FDA asked Gilead to revise its risk-management plan for the drug, Miller said.

She declined to provide details on how Gilead revised this plan, which is known as a risk evaluation and management strategy."

'via Blog this'

If approved, Truvada would become the first drug marketed for prevention of HIV. The FDA will now make a decision by Sept. 14.

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