An Opportunity for Developers and FDA Scientists
As part of FDA’s commitment to promote novel technologies for potential regulatory use, FDA gives developers and others the opportunity to present their new methods and methodologies directly to FDA scientists. Educational opportunities to hear more about new predictive in vitro, in vivo, and in silico methods is vital to ensuring that FDA regulators and researchers have a broad skill set and remain current with cutting-edge science and technology.
How to be Considered for Selection
To be considered for selection, please submit the following information to FDA at:
- A description of your new method or methodology, including origin of cells (if appropriate), species of animal (if appropriate), etc.
- A description of the proposed context of use of your new method or methodology.
- A description of the regulatory issue/gap where it could have an impact on an important regulatory issue.
- Data from use of your method, including any publications.
Your participation in this webinar would mean that your new technology would be introduced to FDA and that individual FDA programs would have the option to contact you for further information. However, your participation in FDA’s webinar series would not constitute FDA’s endorsement of your new method or methodology. Nor would it mean that FDA would assist you in qualifying your new method for regulatory use.
FDA will respond within 60 days to your webinar submission, with either a request for more information, a potential time for your webinar, or a reason why your new technology might not qualify for this program. Although every new technology is exciting to FDA, it may not be mature enough to be incorporated into this program at this time.
This new webinar series joins ongoing FDA initiatives to bring the latest innovative technology to its regulatory and research scientists.