expanded access protocols / clinical protocol / advantage compared to currently approved products / investigational product / manufacturing complexity / manufacturing source / to new unapproved products / manufacturing / clinical trial site / cost recovery protocols / investigational device / drug products / manufacturing costs/complexity / /
MedicalCondition
severe/terminal illness / /
MedicalTreatment
clinical protocol / placebos / /
Organization
Commissioner’s Office / Center for Devices and Radiological Health / C. Office / FDA / Center for Drug Evaluation and Research / OCC / Center for Biologics Evaluation and Research / office of Management / /
Position
investigator / Director for Review Management / supervisor / Director of Deputy Division / CPA / branch chief / Chief Counsel / independent certified public accountant / Director for Policy / clinical investigator / General / Regulatory Project Manager / Associate Director for Review Management / sponsor-investigator / /
Product
authorization / /
ProvinceOrState
Indiana / /
Technology
clinical protocol / approved IND cost recovery protocols / expanded access protocols / drug development / /
SOPP 8203: Evaluation of Cost Recovery Requests for Investigational New Drugs and Investigational Device Exemptions Version 1 Effective Date: January 15, 2013 I. Purpose