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Zdrowie i gospodarka · 10/02/2012

FDA Releases Draft Guidance on Safety Data Collection for Late-Stage Clinical Investigations

The FDA has announced the availability of a draft guidance to help pharmaceutical companies determine the extent of safety data needed for late-stage clinical trials and post-approval studies, aiming to improve the quality of safety assessments without compromising trial results.

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