Posted: 24 Apr 2015 06:51 AM PDT
In a new guidebook published by the Food and Drug Law Institute, David B. Clissold and James E. Valentine of Hyman, Phelps & McNamara, P.C. co-authored Chapter 3-1, “FDA Regulatory Scheme,” and Alexander J. Varond authored Chapter 3-7, “Orphan Drugs.”
Both chapters cover essential elements of development and approval of pharmaceutical products in the United States. The “FDA Regulatory Scheme” chapter provides a thorough overview of FDA’s laws, regulations, and guidance on drug development, including regulatory approval pathways, preclinical and clinical development, expedited development, and postmarket requirements. The “Orphan Drugs” chapter discusses FDA’s orphan drugs program, including the process for requesting orphan drug designation, the benefits associated with designation, and orphan drug exclusivity. The chapter also discusses key aspects of drug development for rare diseases, including FDA’s tropical disease and rare pediatric disease voucher programs, clinical trial design for rare diseases, patient advocacy, special considerations for developing drugs for rare pediatric diseases, and FDA’s historic flexibility in orphan drug approval.
Both chapters cover essential elements of development and approval of pharmaceutical products in the United States. The “FDA Regulatory Scheme” chapter provides a thorough overview of FDA’s laws, regulations, and guidance on drug development, including regulatory approval pathways, preclinical and clinical development, expedited development, and postmarket requirements. The “Orphan Drugs” chapter discusses FDA’s orphan drugs program, including the process for requesting orphan drug designation, the benefits associated with designation, and orphan drug exclusivity. The chapter also discusses key aspects of drug development for rare diseases, including FDA’s tropical disease and rare pediatric disease voucher programs, clinical trial design for rare diseases, patient advocacy, special considerations for developing drugs for rare pediatric diseases, and FDA’s historic flexibility in orphan drug approval.
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