Zdrowie i gospodarka · 12/12/2018

FDA Proposes Changes to Definition of Biological Product

The FDA is proposing to update its regulation of biological products, including proteins and chemically synthesized polypeptides, to align with the Biologics Price Competition and Innovation Act of 2009 and provide clearer guidance on the terms 'protein' and 'polypeptide'.

Source: Federal Register — Food and Drug AdministrationOpen original release →

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