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Draft guidelines on human gene therapies released by FDA's CBER

06:42 EDT 13 Jul 2018 | SmartBrief

The FDA's Center for Biologics Evaluation and Research issued six new draft guidance documents Wednesday regarding human gen -More

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The field encompassing therapeutic materials produced using biological means, including recombinant DNA technology. Biotherapeutics, also known as biotech drugs or biologics, are therapies derived from living organisms. By harnessing these living cells...