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
, Partner, BakerHostetler
This session was recorded as part of FDLI’s Introduction to Drug Law and Regulation Course in November 2022.
- +$100 for nonmembers
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