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Zdrowie i gospodarka · 20/06/2014

FDA Releases Draft Guidance for Environmental Assessments of Gene Therapies and Vaccines

The FDA has made available a draft document outlining recommendations for determining the need and content of environmental assessments for gene therapies, vectored vaccines, and related products, with the goal of streamlining the process for industry sponsors and applicants.

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