Table of Contents
Because of how many acronyms they each have mastered!
PPT Slide
FDA’s Pediatric Team
PhRMA’s Commitment to Pediatric Drug Development
Identification of Therapeutic Areas in Need of Drugs for Children
International Conference on Harmonization (ICH)
Resolving the Problems Posed by Multi-source Products
Cross Labeling of “Me Too Drugs”
FDA’s Current Processing of Selected Pediatric Issues
PhRMA Concerns:
PhRMA Concerns:
PhRMA Concerns:
PhRMA’s Concerns:
Need for FDA to Promptly Issue a Draft Guidance (which may have already started)
PhRMA Participation in Subcommittee’s Work
Clinical Trials
Clinical Trials
Clinical Trials
Clinical Trials
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