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Zdrowie i gospodarka · 17/12/2009

FDA Publishes Draft Guidance on Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals

The FDA has released a draft guidance document outlining recommendations for nonclinical studies to support the safety of biotechnology-derived pharmaceuticals, building on the International Conference on Harmonisation's (ICH) S6 guidance published in 1997.

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