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)