FDA Regulatory Affairs

This training focuses on understanding of the regulatory requirements necessary to bring Drugs, Biotech Products and Medical Devices to market in the US.

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