Anne Wyllie Nomination for FDA Foundation 2022 Innovations in Regulatory Science Awards The Reagan-Udall Foundation nomination argues that Anne Wyllie’s SalivaDirect EUA pioneered an “open source protocol” model by validating saliva and extraction-free processing while disclosing components and qualifying multiple reagent/instrument options for broad CLIA lab adoption. It highlights the FDA “designation” approach, legal and operational infrastructure for scaling a lab network, and downstream effects such as supply-chain resilience and industry-wide cost compression in molecular testing. The nomination frames SalivaDirect as a template for “generic” diagnostics authorization with relevance to future pandemic preparedness, while disclosing FloodLAMP’s advisory relationship to Wyllie. primary file regulatory open-euas Anne Wyllie Nomination for FDA Foundation 2022 Innovations in Regulatory Science Awards.md regulatory/open-euas/Anne Wyllie Nomination for FDA Foundation 2022 Innovations in Regulatory Science Awards.md 2022_06_03 gdoc docx CC BY 4.0 - https://creativecommons.org/licenses/by/4.0/ 1034 1428 gfile-url xfile-github-download-url pdf-gdrive-url pdf-github-url github-markdown-url github-markdown-download-url web-pdf-url web-slides-url youtube-url web-url