Regulation of Drug Manufacturing: An Introduction A session from FDLI’s Introduction to Drug Law and Regulation Recorded April 22-23, 2025 Regulation of Drug Manufacturing: An Introduction Learn Current Good Manufacturing Practices (cGMPs) for drugs and be able to define “adulteration” and “misbranding”. Understand the [...]
Regulation of Over-the-Counter (OTC) Drugs A session from FDLI’s Introduction to Drug Law and Regulation Recorded April 22-23, 2025 Regulation of Over-the-Counter (OTC) Drugs Learn how Over-the-Counter (OTC) drugs are regulated by the FDA. Understand the history of the OTC Drug Review Process. Explore [...]
The Regulation of Biologics and Biosimilars: An Introduction A session from FDLI's Introduction to Drug Law and Regulation Recorded April 22-23, 2025 The Regulation of Biologics and Biosimilars: An Introduction Understand differences between biologics and small molecule drugs and effect on regulating generic drugs [...]
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Post-Approval Requirements for Drugs: An Introduction to Safety Reporting and Post-Approval Changes A session from FDLI's Introduction to Drug Law and Regulation Recorded April 22-23, 2025 Post-Approval Requirements for Drugs: An Introduction to Safety Reporting and Post-Approval Changes Understand regulatory requirements for post-approval safety [...]
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 [...]
