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BioPharmaceutical United States Post Market Regulation & Studies

Pregnancy Labeling Changes May Spur Research, FDA Says

This article was originally published in The Pink Sheet Daily

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Executive Summary

Final regulation eliminates use of letter-based categories to designate level of risk during pregnancy and lactation; in a change from the 2008 proposed rule, information relevant to drug effects on reproductive potential will now be housed in dedicated section.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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