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BIO Comments on FDA Draft Guidance on Postapproval Pregnancy Safety Studies

July 1, 2019

BIO submitted comments on the Food and Drug Administration (FDA) Draft Guidance on Postapproval Pregnancy Safety Studies.

BIO expresses support for the goal of enhancing the medical community’s knowledge of the effects of medicines on pregnant women. In addition, BIO commends the FDA for welcoming the use of other types of post-approval studies other than pregnancy registries to monitor the safety of products during pregnancy.

BIO notes the majority of the guidance is focused on pregnancy registries, implying they are the default mechanism for conducting pregnancy surveillance after marketing. BIO urges FDA to consider amending the guidance and consider all possible limitations of pregnancy registries and all possible methods of pregnancy surveillance as well as the use of existing systems to collect and evaluate pregnancy information, such as pharmacovigilance studies.

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BIO Letter Post Appoval Pregnacny Safety Study FDA-2018-D-4693
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