Analysis Life Sciences Thank You A closer look at CDER’s new 2024 guidance agenda
Agency IQ
FEBRUARY 12, 2024
Another guidance will focus on pharmacokinetics in pregnancy, likely replacing a 2004 guidance document that the FDA never finalized, while a guidance the creation of a “REMS Logic Model” framework is meant to “link program design with assessment” – something called for in the most recent PDUFA VII commitment letter.
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