Recorded November 15, 2023 | On-Demand Webinar
Access to recordings of virtual introductory courses is limited to one year from the date of purchase as we update programs annually.
• 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 2023.