Assuring Access to Safe Medicines in Pregnancy and Breastfeeding

Author:

Nooney Janet1,Thor Shannon2,Vries Corinne3,Clements John1,Sahin Leyla2,Hua Wei2,Everett Darcie2,Zaccaria Cosimo3,Ball Robert2,Saint‐Raymond Agnes3,Yao Lynne2,Raine June1,Kweder Sandra2

Affiliation:

1. Medicines and Healthcare products Regulatory Agency London UK

2. US Food and Drug Administration Silver Spring Maryland USA

3. European Medicines Agency Amsterdam The Netherlands

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference22 articles.

1. US FDA.Content and Format of Labeling for Human Prescription Drug and Biological Products: Requirements for Pregnancy and Lactation Labeling.(2014).

2. US HHS.Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC).(2017).

3. UK Commission on Human Medicines.Report of the Commission on Human Medicines’ Expert Working Group on Hormone Pregnancy Tests.(2017).

4. US HHS.PRGLAC Report to Congress.(2018).

5. US FDA.Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials: Draft Guidance for Industry.(2018).

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