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

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Recorded November 9, 2022 | On-Demand Webinar

• 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



This session was recorded as part of FDLI’s virtual Introduction to Drug Law and Regulation course in November 2022.

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