Specialty Pharma Journal Specialty, Precision & Technology
Once just a theory, gene therapies are now a therapeutic reality for some patients. These platforms may have the potential to treat and cure some of our most intractable and vexing diseases. The policy framework we construct for how these products should be developed, reviewed by regulators, and reimbursed, will …
Tag Archives: guidance
July, 2018
August, 2016
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29 August
FDA Advises Testing for Zika Virus in all Donated Blood and Blood Components in the US
As a further safety measure against the emerging Zika virus outbreak, today the U.S. Food and Drug Administration issued a revised guidance recommending universal testing of donated Whole Blood and blood components for Zika virus in the U.S. and its territories. “There is still much uncertainty regarding the nature and …
March, 2016
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2 March
New Guidelines from the FDA Aim to Prevent Zika Transmission through Tissue, Cell Donation
As an additional safety measure against the emerging Zika virus outbreak, the U.S. Food and Drug Administration today issued new guidance for immediate implementation providing recommendations to reduce the potential transmission risk of Zika virus from human cells, tissues, and cellular and tissue-based products (HCT/Ps). The guidance addresses donation of …