Evaluation: 2024 November Introduction to Drug - Food and Drug Law Institute (FDLI)

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Evaluation: 2024 November Introduction to Drug

Evaluation: 2024 November Introduction to Drug Law and Regulation

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What topics addressed at the conference did you find most valuable?

Preconference Primer 1: Overview of Drug Law and Regulation with Alan G. Minsk
Preconference Primer 2: The New Drug Approval Process: Basic Concepts with David R. Joy
Session 3: The New Drug Approval Process: New Drug Research and Development with Justin Coen
Session 4: The New Drug Approval Process: NDA Submission and Review with Nathan A. Beaver
Session 5: The Abbreviated NDA (ANDA), 505(b)(2) Applications, and Patent and Exclusivity Issues with Kathleen Treaster
Session 6: Post-Approval Issues with Julia Marré
Session 7: Biologics and Biosimilars with Christopher M. Mikson
Session 8: Regulation of Over-the-Counter (OTC) Drugs with Deborah L. Livornese
Session 9: Regulation of Drug Manufacturing with Paula Katz
Session 10: Regulation of Drug Marketing with Marc J. Scheineson and Devaki Patel
Session 11: Violations and Enforcement with Marc Wagner

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