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2023 Topics
M13 update on comments
RWE/RWD – real-world evidence / real-world data
Product specific GDLs
Clinical pharmacology and pharmacokinetics: questions and answers
Comparison of individual excipients, BCS-based biowaivers, questions from Agencies
WEU (10a)
– back to roots
GDL on drug interaction – impact to FDCs
Biosimilars – where we go in the future (e.g., fast-acting insulin, GLP1)
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