An Introduction to the Abbreviated NDA (ANDA), 505(b)(2) Applications, and Patent and Exclusivity Issues A session from FDLI’s Introduction to Drug Law and Regulation Recorded November 19–20, 2024 An Introduction to the Abbreviated NDA (ANDA), 505(b)(2) Applications, and Patent and Exclusivity Issues Understand the [...]
The New Drug Approval Process: NDA Submission and Review A session from FDLI's Introduction to Drug Law and Regulation Recorded April 22-23, 2025 The New Drug Approval Process: NDA Submission and Review Recognize the content and organization of a full New Drug Application. Become [...]
The New Drug Approval Process: New Drug Research and Development A session from FDLI's Introduction to Drug Law and Regulation Recorded April 22-23, 2025 The New Drug Approval Process: New Drug Research and Development Learn the requirements of Good Laboratory Practices (GLP) and Good [...]
The New Drug Approval Process: Basic Concepts A session from FDLI's Introduction to Drug Law and Regulation Recorded April 22-23, 2025 The New Drug Approval Process: Basic Concepts Recognize the difference between a “drug” and a “new drug” under the Federal Food Drug and [...]
Origins and Overview of Drug Law Regulation: An Introduction A session from FDLI's Introduction to Drug Law and Regulation Recorded April 22-23, 2025 Origins and Overview of Drug Law Regulation: An Introduction Learn the current regulatory framework and major statutory underpinnings for drug [...]
Topic Suggestions Is there a specific topic you would like to see addressed in a future FDLI event? If so, please share your suggestions on our online portal.
Topic Suggestions Is there a specific topic you would like to see addressed in a future FDLI event? If so, please share your suggestions on our online portal.
Topic Suggestions Is there a specific topic you would like to see addressed in a future FDLI event? If so, please share your suggestions on our online portal.
Digital Health Technology and Regulation Conference February 26–February 27, 2024 | Virtual Event Overview Agenda Speakers Details Continuing Legal Education
Digital Health Technology and Regulation Conference February 26–27, 2025 | Virtual Event Overview Agenda Details Preliminary Agenda Agenda Subject to Change All Times Listed are Eastern Time Wednesday, February 26 FDLI WelcomeChristine M. Simmon, President and CEO, FDLI [...]
