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FDA Tox Working Group

This publication explores the integration of predictive technologies and replacing animal tests as key goals of the FDA Roadmap. It delves into the importance of FDA stakeholders and their collaboration towards achieving these objectives. The text highlights the significance of training courses in partnership with stakeholders and recommends relevant sources for such courses. It emphasizes improved communication strategies for FDA stakeholders and encourages early discussion on new toxicology methods. Moreover, the text discusses the integration of new toxicology approaches into FDA product reviews and outlines necessary information stakeholders require for alternative method qualification. Lastly, it suggests collaborations and research initiatives to enhance FDA's mission and promote transparency in its regulatory process.

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FDA Tox Working Group

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  1. FDA Tox Working Group Which goals of the FDA Roadmap are most important to FDA stakeholders? • Integration of predictive technologies • Replacing animal tests

  2. Training Should FDA partner with its stakeholders for these training courses and how might this be achieved? • Absolutely, let’s partner! Are there relevant courses that you can recommend? • ASCCT webinars • Institute for In Vitro Sciences • CE courses on predictive tox at scientific conferences • Private companies

  3. Communication How can FDA better communicate with stakeholders to encourage discussion on the use of qualified new toxicology methods early in the regulatory process? • Policy statement/Guidance • Maintain running list of qualified methods

  4. Communication Cont How can new toxicology methods and approaches be integrated into FDA’s review of regulated products? • Review scientific merits of all applications and provide substantive feedback What information do stakeholders need from FDA to qualify alternative methods for a specific COU? • Conduit for data sharing of submitted data

  5. Communication Cont Other • Regulations • Guidance

  6. 21 C.F.R. § 312.23(a)(5)(ii) Current Regulatory Text: “A summary of the pharmacological and toxicological effects of the drug in animals, and, to the extent known, in humans.” Proposed Regulatory Text: “A summary of the pharmacological and toxicological effects of the drug in nonclinical approaches, and, to the extent known, in humans.”

  7. Collaborations What partnerships could be useful to FDA to advance the roadmap? • Nonclinical Innovation and Patient Safety Initiative (NIPSI) • American Society for Cellular and Computational Toxicology (ASCCT) • Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM)

  8. Research How can FDA encourage and support research in areas of importance to its mission? • Microphysiological Systems IQ Consortium • National Center for Advancing Translational Sciences (NCATS) Tissue Chip Collaboration

  9. Oversight How can FDA ensure transparency in its progress? • Create avenue for communication with leadership if agency unresponsive to requests to help with implementation • Required reports to Chief Scientist made public

  10. Elizabeth Baker, Esq. Pharmaceutical Policy Program Director ebaker@pcrm.org

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