Zdrowie i gospodarka · 11/05/2026

Postapproval Pregnancy Safety Studies; Guidance for Industry; Availability

The Food and Drug Administration (FDA) has released a final guidance for industry titled 'Postapproval Pregnancy Safety Studies,' which provides recommendations for designing investigations to assess the outcomes in pregnant women exposed to FDA-regulated products. This guidance finalizes a draft issued on May 9, 2019.

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

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