The Food and Drug Administration has approved efavirenz, a new drug, to treat HIV and AIDS in children and adults. Efavirenz , in combination with other antiretroviral agents, was approved to treat HIV-1 infection after 24-week studies showed it to be effective in suppressing HIV. The effect of efavirenz on viral suppr
The Food and Drug Administration today proposed rules allowing greater flexibility for manufacturers to disseminate information -- such as studies published in scientific journals -- about the safety, effectiveness or benefits of off label uses for marketed drugs, biologics and medical devices. This information can onl
Food and Drug Administration (FDA),U.S. Department of Health and Human Services - January 5, 1998
The Food and Drug Administration today published a draft guidance concerning promotional practices by pharmacy benefits management companies (PBMs) and similar enterprises that are owned or influenced by the sponsors of medical products. Today s Federal Register carries a notice of the availability of this draft guidan
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