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Review
. 2021 Oct;110(4):941-945.
doi: 10.1002/cpt.2212. Epub 2021 May 1.

Assuring Access to Safe Medicines in Pregnancy and Breastfeeding

Janet Nooney  1 , Shannon Thor  2 , Corinne de Vries  3 , John Clements  1 , Leyla Sahin  2 , Wei Hua  2 , Darcie Everett  2 , Cosimo Zaccaria  3 , Robert Ball  2 , Agnes Saint-Raymond  3 , Lynne Yao  2 , June Raine  1 , Sandra Kweder  2
Affiliations
Review

Assuring Access to Safe Medicines in Pregnancy and Breastfeeding

Janet Nooney et al. Clin Pharmacol Ther. 2021 Oct.

Abstract

Scientists and regulators in Europe and the United States continue to seek methods and strategies to improve knowledge on rational use of medicines for pregnant and breastfeeding populations, an important subset of women's health. Regulatory agencies have made strides toward improvement, but much more is needed. Recognizing the importance of international collaboration, we have begun to consider how to address these important public health issues more globally. The health of the child begins with the health of the mother.

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Conflict of interest statement

The authors declared no competing interests for this work.

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References

    1. US FDA . Content and Format of Labeling for Human Prescription Drug and Biological Products: Requirements for Pregnancy and Lactation Labeling. (2014). - PubMed
    1. US HHS . Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC). (2017). - PMC - PubMed
    1. UK Commission on Human Medicines . Report of the Commission on Human Medicines’ Expert Working Group on Hormone Pregnancy Tests. (2017).
    1. US HHS . PRGLAC Report to Congress. (2018).
    1. US FDA . Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials: Draft Guidance for Industry. (2018).

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