Biosimilars Clinical Pharmacology Pharmaceuticals Pharmacokinetics 
Drug Discovery World
JULY 25, 2023
The pharmaceutical industry is constantly developing evidence-based treatments for children while there continue to be scientific advancements related to new modalities and disease understanding. General clinical pharmacology This FDA draft guidance was previously issued in 2014 but was re-issued for comments again in 2022.
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.
Agency IQ
FEBRUARY 15, 2024
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