Drug Regulators, FDA, Publish Recommendations for Management of Donor at Increased Risk of HIV-1 infection.
The Food and Drug Administration (FDA), are providing the, blood and plasma establishments, with a revised list of countries that should be included in questions for identifying donors at increased risk for HIV-1 group O infection. They are also providing recommendations for discontinuing the use of some questions used to identify these donors and for management of donors previously deferred. This guidance supersedes the memorandum entitled “Interim Recommendations for Deferral of Donors at Increased Risk for HIV-1 Group O Infection,” dated December 11, 1996 (Ref. 1). That memorandum contained interim measures to reduce the risk of HIV-1 group O transmission by blood and blood products pending licensure of test kits specifically labeled for detection of antibodies to HIV-1 group O viruses. Now that an FDA-licensed test for detection of antibodies to HIV-1 group O viruses is available, those interim recommendations are no longer current.
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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
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