Bringing Your Pharmaceutical Drug to Market

April 1, 2015

David Clissold and James Valentine* co-authored Chapter 3-1, “FDA Regulatory Scheme” and Alexander Varond authored Chapter 3-7, “Orphan Drugs” in the Food and Drug Law Institute’s guidebook Bringing Your Pharmaceutical Drug to Market.

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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If you have any questions regarding the above information, please contact:
David B. Clissold (202) 737-7545
Alexander J. Varond (202) 737-4594
James E. Valentine* (202) 724-1745

*Admitted only in Maryland. Work supervised by the Firm while D.C. application pending.

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