FDA新药审核流程.pdf

Selected Topics on Selected Topics on New Drug Development New Drug Development and Review Process and Review Process Zili Li, MD, MPH Division of Reproductive and Urologic Drug Products FDA/CDER/OND/ODEIII July 24, 2003 Disclaimer Disclaimer The opinions included herein The opinions included herein are those of the presenter, and are those of the presenter, and do not necessarily reflect those do not necessarily reflect those of the FDA of the FDA Objectives Objectives Introduce selected concepts on new Introduce selected concepts on new drug development and review process, drug development and review process, such as such as Drug v.s. Non-drug Drug v.s. Non-drug IND v.s. NDA IND v.s. NDA Phase I v.s. II v.s. III Clinical Trials Phase I v.s. II v.s. III Clinical Trials Benefit v.s. Risk Benefit v.s. Risk How to find more drug-related How to find more drug-related information from FDA Website information from FDA Website What is FDA ? What is FDA ? A federal agency to ensure the safety or A federal agency to ensure the safety or the safety and effectiveness of the the safety and effectiveness of the products under its jurisdiction. products under its jurisdiction. These products are worth about a trillion These products are worth about a trillion dollars a year and make up 22% of all dollars a year and make up 22% of all consumer expenditures in the United consumer expenditures in the United States. States. Products Under FDA Jurisdiction Products Under FDA Jurisdiction Food Food Cosmetic