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FDA may expand clinical investigator restrictions
The Food and Drug Administration is proposing to amend its regulations to expand the scope of clinical investigator disqualification. Under this proposal, when the Commissioner of Food and Drugs determines that an investigator is ineligible to receive certain test articles (drugs, devices, or new animal drugs), the investigator also will be ineligible to conduct any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA.
The proposed rule is available at: http://1.usa.gov/jQfjtl
Comments to this proposed rule are due by July 12, 2011.
Nevirapine extended release tab approved
On March 25, 2011, the Food and Drug Administration (FDA) approved nevirapine (Viramune XR®) 400 mg extended release tablet.
Nevirapine XR is indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults.
The approval is based on one principal clinical trial (1100.1486) that demonstrated prolonged suppression of HIV-1 RNA through 48-weeks, and a supportive trial (1100.1526).
Based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled studies, nevirapine should not be initiated in adult females with CD4+ cell counts greater than 250 cells/mm3 or in adult males with CD4+ cell counts greater than 400 cells/mm3 unless the benefit outweighs the risk.
The 14-day lead-in period with immediate-release nevirapine 200 mg daily dosing must be strictly followed; it has been demonstrated to reduce the frequency of rash.