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- 505(b)(2) Regulatory Planning: Creating Value for Patients and Sponsors
- Achieving Long-Term Success for Your Development Program — Mark McCamish
- Achieving Long-Term Success for Your Development Program — Mike Dial and Tim Sullivan
- Challenges and Opportunities in Rare Pediatric Drug Development
- How Commercial Insights Can be Used to Maximize an Early Exit
- Let’s Get Real: The Growing Importance of RWD and RWE in Regulatory Decision-Making
- Leveraging the Target Product Profile (TPP) to Maximize Breakthrough Potential
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- The Pediatric Research Equity Act (PREA) and Its Implications for Oncology Development
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- Understanding New FDA Guidance For Pediatric Oncology Studies: A Sponsor’s Guide to the FDA Research to Accelerate Cures and Equity for Children Act
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