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FDA issues draft guidance for post-approval biologics changes

05:50 EDT 17 Aug 2017 | SmartBrief

A draft guidance from the FDA detailed changes in post-approval manufacturing documentation for biologics, noting that major  -More

Original Article: FDA issues draft guidance for post-approval biologics changes

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Biotherapeutics
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...