FDA issues guidelines for HIV drugs

FDA issues guidelines for HIV drugs
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The Food and Drug Administration (FDA) is looking to assert more control over HIV drug manufacturers.

Pharmaceutical companies are now facing new guidelines for developing drugs to treat Human Immunodeficiency Virus, which causes AIDS.

The FDA guidance issued Monday will provide recommendations for drug manufacturers developing HIV therapeutic biologic products and antiretroviral drugs.

The HIV guidelines will cover “all phases of development,” according to the FDA, from non-clinical research and the early stages of clinical development to protocol designs and treatment end points.

The FDA is primarily concerned about drugs aimed at helping “treatment-experienced patients” who are HIV-positive and are not responding well to other drugs. 

The FDA’s guidance does not carry the same weight as a formal rule, but its recommendations can influence industry.

The public can submit comments at any time.