Anne Wyllie Nomination for FDA Foundation 2022 Innovations in Regulatory Science Awards The "Anne Wyllie Nomination for FDA Foundation 2022 Innovations in Regulatory Science Awards" document argues that Anne Wyllie’s SalivaDirect EUA pioneered an “open source protocol” model by 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 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