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Abernethy A, et al. Statement from Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D., and Janet Woodcock, M.D., director of FDA's Center for Drug Evaluation and Research, on policies designed to capture more data to better understand effects of prescription drugs in pregnant and nursing women. Internet Document : 8 May 2019. Available from: URL: https://www.fda.gov/news-events/press-announcements/statement-principal-deputy-commissioner-amy-abernethy-md-phd-and-janet-woodcock-md-director-fdas
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Draft guidances to capture data for pregnant/breastfeeding women. Reactions Weekly 1754, 2 (2019). https://doi.org/10.1007/s40278-019-62235-3
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DOI: https://doi.org/10.1007/s40278-019-62235-3