Zdrowie i gospodarka · 29/12/2016
FDA Releases Guidance on Clinical Pharmacology Data for Biosimilar Products
The US Food and Drug Administration (FDA) has finalized a guidance document to help pharmaceutical companies and researchers develop biosimilar products by providing the necessary clinical pharmacology data, as mandated by the Biologics Price Competition and Innovation Act of 2009.
Source: Federal Register — Food and Drug AdministrationOpen original release →