FDA Regulatory Affairs

Topics to be discussed include:

• Overview of FDA and Drug Development
• IND (Investigational New Drug) Application
• NDA (New Drug Application)
• Module 1 – Administrative and Prescribing Information
• Module 2 – Common Technical Document Summary
• Module 3 – Quality
• Module 4 – Nonclinical Study Reports
• Module 5 – Clinical Study Report
• FDA Medical Device Regulation
• The 510 (k) Premarket Notification – Traditional, Special, Abbreviated, De Novo
• The PMA (Pre Market Approval) Application