Search Results - "Epps, Carla"
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Inclusion of Infants and Neonates in Pediatric Orphan Product Approvals
Published in Clinical pharmacology and therapeutics (01-10-2021)“…The Orphan Drug Act (ODA) of 1983 was enacted to provide financial incentives to drug sponsors to develop therapies for rare diseases. Although this act…”
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Global Regulatory and Public Health Initiatives to Advance Pediatric Drug Development for Rare Diseases
Published in Therapeutic innovation & regulatory science (01-11-2022)“…The literature thoroughly describes the challenges of pediatric drug development for rare diseases. This includes (1) generating interest from sponsors, (2)…”
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Health Equity in Pediatric Drug Development: Translating Aspiration into Operation
Published in Therapeutic innovation & regulatory science (01-11-2022)“…The concept of health equity-the attainment of the highest possible level of health for all members of society-requires equitable access to all aspects of…”
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