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

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