FDA accepting proposals for alternative methods webinar series

The Office of the Chief Scientist of the U.S. Food and Drug Administration (FDA) is launching a webinar series on alternative methods. The webinar series supports FDA’s commitment to promote novel technologies and potentially incorporate them into its regulatory review, as applicable.

Test method developers who participate in this webinar series will have the opportunity to introduce their new technology to FDA and give individual FDA programs the option to contact them for further information. Please note, however, that participation in FDA’s webinar series does not constitute FDA’s endorsement of a new method or oblige FDA to assist the developer in qualifying a new method for regulatory use.

To be considered for the webinar series, please submit the following information to alternatives@fda.gov:

• A description of your new method, including origin of cells or species of animal if appropriate.
• A description of the proposed context of use of your new method.
• A description of the regulatory issue/gap where the new method could have an impact.
• Data from use of your method, including any publications.

FDA will respond within 60 days to your webinar submission. For more information, visit https://www.fda.gov/science-research/about-science-research-fda/fda-webinar-series-alternative-methods-showcasing-cutting-edge-technologies-disease-modeling