Zdrowie i gospodarka · 29/06/2018
FDA Releases Final Guidance on Biosimilar User Fee Amendments of 2017
The Food and Drug Administration has announced the availability of a final guidance document outlining how to assess user fees under the Biosimilar User Fee Amendments of 2017, a law that affects the agency's interaction with biosimilar manufacturers.
Source: Federal Register — Food and Drug AdministrationOpen original release →