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BIO Comments on FDA Draft Guidance on Scientific and Ethical Considerations for Including Pregnant Women in Clinical Trials

June 8, 2018

BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials Guidance for Industry.

This guidance is an important step towards providing information to patients and providers about the safety and efficacy of therapies for pregnant women. The guidance provides insight to sponsors on how and when to include pregnant women in drug development clinical trials.

BIO provided general and detailed comments to clarify the draft guidance, including what types of studies it applies to, terminology such as the meaning of "nonpregnant women," and how to analyze and interpret data obtained from pregnant women in clinical trials that are not for medical products specifically indicated for pregnant women.

Download Full Comments Below
BIO Letter Pregnant Women Scientific And Ethical Considerations For Inclusion In Clinical Trials Guidance For Industry FDA-2018-D-1201
Read full comment letter below
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