sábado, 30 de julio de 2016

Comment on Current FDA Draft Guidances > Opportunities to Comment Closing November 2016

Comment on Current FDA Draft Guidances > Opportunities to Comment Closing November 2016



The FDA is establishing a public docket and requesting comments, supported by scientific evidence, regarding potential blood donor deferral policy options to reduce the risk of human immunodeficiency virus (HIV) transmission by blood and blood products.  
Specifically, the FDA is inviting comments on the feasibility of moving from the existing time-based deferrals related to risk behaviors to alternate deferral options, such as the use of individual risk assessment.
The FDA is also seeking comments regarding the design of potential studies to evaluate the feasibility or effectiveness of such alternative deferral policy options.
The FDA will consider comments and supporting scientific evidence received as it continues to reevaluate and update blood donor deferral policies.
The comment period is 120 days.
Steve Morin
Office of Health and Constituent Affairs
Food and Drug Administration
Richard Klein
Office of Health and Constituent Affairs
Food and Drug Administration
For more information about the HIV Liaison Program visit the FDA Patient Network

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