January 11, 2021 Publication

FDA Report on Advancing Alternative Methods


Dr. Susanne Fitzpatrick, senior advisor for toxicology at FDA about the report: ‘The report entitled Advancing Alternative Methods at FDA was developed by the FDA Alternative Methods Working Group to highlight the significant progress FDA scientists have made in our product centers and offices in laying the groundwork for integrating alternative approaches into FDA regulatory programs. It demonstrates FDA’s strong commitment to reducing animal testing and to encouraging stakeholders to continue partnering with FDA to achieve this important goal.

FDA scientists have vast expertise and experience using available tools to make tough scientific decisions about the safety and effectiveness of the multitude of therapeutic products in our regulatory portfolio. Many of the important research activities on alternative methods described in this report are being conducted in FDA laboratories, and many of these include collaborations with outside stakeholders. Results from these ground-breaking research activities add to the body of knowledge that FDA can draw upon as it evaluates regulatory acceptance criteria for new alternative methods.

FDA believes partnerships between our diverse programs and outside stakeholders are essential to furthering progress in developing strong alternative approaches. FDA is open to dialogue from all sectors of the population because we believe it will strengthen our scientific and regulatory thinking’.

The report is available here.

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