Pregnant and breastfeeding women are often excluded from clinical trials, leaving critical data gaps. To address this, the US FDA requires structured post-approval monitoring including pregnancy exposure registries, complementary real-world studies, lactation studies, and PLLR-compliant labeling updates.
At AWINSA Life Sciences, we help sponsors navigate these requirements by designing registries, integrating findings into PV systems, and ensuring accurate FDA labeling that safeguards mothers and infants. Read our white paper to see how we can help you stay compliant and patient-focused.
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