National Academies Recommend Use of PREA and BPCA as Models for Studies Involving Pregnant and Lactating Women

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National Academies Recommend Use of PREA and BPCA as Models for Studies Involving Pregnant and Lactating Women

More and Better Guidance Needed From FDA and OHRP

J.W. Schomisch

April 15, 2024 at 12:42 PM EST

Congress needs to pass laws requiring clinical research involving pregnant and lactating women to be modeled on the Pediatric Research Equity Act (PREA) and the Best Pharmaceuticals for Children Act (BPCA), according to the National Academies of Sciences, Engineering, and Medicine (NASEM). In addition, the institutions said, the FDA and the Department of Health and Human Servi... Read More

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National Academies Recommend Use of PREA and BPCA as Models for Studies Involving Pregnant and Lactating Women

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