Pregnancy Registries Are Insufficient To Assess Drug Safety, US FDA Says
Draft guidance recommends complementary studies to evaluate effects of drug use during pregnancy; FDA may require lactation studies more frequently.
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The European Medicines Agency is developing a strategy to ensure that women have sufficient information to make informed choices about taking medicines during pregnancy and breastfeeding.
Agency’s postmarketing requirements to assess Vyleesi risk in pregnant and lactating women highlight the changes catalyzed by draft guidances issued in April.
New techniques cannot replace registries but can address their limitations, stakeholders tell FDA.