2025 FDA Bulk Registration Rate Form
Cannabis Regulation: FDA, State, and Stakeholder Perspectives Agenda
Cannabis Regulation: FDA, State, and Stakeholder Perspectives March 26, 2025 | In-Person & Virtual Event Overview Agenda Details Last Year's Agenda A preliminary agenda will be announced in late January 2025. If you would like to be notified, please [...]
An Introduction to Drug Enforcement: FDA Enforcement Authorities, Tools, Violations and Initiatives
An Introduction to Drug Enforcement: FDA Enforcement Authorities, Tools, Violations, and Initiatives A session from FDLI’s Introduction to Drug Law and Regulation Recorded April 22-23, 2025 An Introduction to Drug Enforcement: FDA Enforcement Authorities, Tools, Violations, and Initiatives Understand the sources and scope of [...]
Regulation of Drug Marketing: An Introduction
Regulation of Drug Marketing: An Introduction A session from FDLI’s Introduction to Drug Law and Regulation Recorded April 22-23, 2025 Regulation of Drug Marketing: An Introduction Learn to differentiate between “label” and “labeling” and “false and “misleading”. Gain insight on FDA’s social media guidance, [...]
Regulation of Drug Manufacturing: An Introduction
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: An Introduction
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
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 [...]
Evaluation: 2024 November Elections Webinar
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.
Post Approval Requirements for Drugs: An Introduction to Safety Reporting and Post-Approval Changes
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
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 [...]
