Post-Approval Requirements for Drugs: An Introduction to Safety Reporting and Post-Approval Changes

Understand regulatory requirements for post-approval safety reporting

  • Explain FDA’s drug safety activities
  • Describe the regulatory framework for post approval changes and supplemental New Drug Applications (NDAs) and Abbreviated NDAs (ANDAs)
  • Understand at a high-level:
    • Grounds for Withdrawal of Approval
    • Medicare, Medicaid and Reimbursement Issues
    • Drug Supply Chain Security Act (DSCSA) Product Tracing Requirements

David L. Rosen, Partner, Foley & Lardner LLP

This session was recorded as part of FDLI’s Introduction to Drug Law and Regulation Course in April 2022. 

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