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February 27, 2025
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Presentations
About This Course
The FDA’s Office of Generic Drugs (OGD) plays a critical role in ensuring access to safe, effective, and affordable generic drugs. To facilitate the development and approval process, the FDA offers various pathways for communication, including controlled correspondence.
This event offers a comprehensive overview of controlled correspondence as an efficient pathway for communication with the FDA regarding generic drug development. FDA will host a panel discussion on topics pertinent to the generic drug industry, and answer questions during live Q&A sessions with FDA experts.
Intended Audience
This webinar is designed for generic drug developers and regulatory professionals looking to streamline their interactions with the FDA with the usage of Controlled Correspondence.
Topics Covered
- Navigating formulation assessments
- Navigating controlled correspondences related to bioequivalence approaches/studies
- Clinical pharmacology topics in generic drug development
- Role of controlled correspondences in supporting the safety evaluation of generic drugs