The next forum for unraveling FDA off-label marketing rules: State and federal legislatures.

by Michael S Sinha, Aaron S Kesselheim
Published 2018-05-01

Assessing the filtration efficiency and regulatory status of N95s and nontraditional filtering face-piece respirators available during the COVID-19 pandemic

by Deborah Plana, Enze Tian, Avilash K. Cramer, Helen Yang, Mary M. Carmack, Michael S. Sinha, Florence T. Bourgeois, Sherry H. Yu, Peter Masse, Jon Boyer, Minjune Kim, Jinhan Mo, Nicole R. LeBoeuf, Ju Li, Peter K. Sorger
Published 2021-07-01

Analysis of SteraMist ionized hydrogen peroxide technology in the sterilization of N95 respirators and other PPE

by Avilash K. Cramer, Deborah Plana, Helen Yang, Mary M. Carmack, Enze Tian, Michael S. Sinha, David Krikorian, David Turner, Jinhan Mo, Ju Li, Rajiv Gupta, Heather Manning, Florence T. Bourgeois, Sherry H. Yu, Peter K. Sorger, Nicole R. LeBoeuf
Published 2021-01-01

A Crisis-Responsive Framework for Medical Device Development Applied to the COVID-19 Pandemic

by Marc-Joseph Antonini, Marc-Joseph Antonini, Marc-Joseph Antonini, Marc-Joseph Antonini, Deborah Plana, Deborah Plana, Deborah Plana, Shriya Srinivasan, Shriya Srinivasan, Shriya Srinivasan, Shriya Srinivasan, Lyla Atta, Lyla Atta, Aditya Achanta, Aditya Achanta, Helen Yang, Helen Yang, Avilash K. Cramer, Avilash K. Cramer, Jacob Freake, Jacob Freake, Michael S. Sinha, Michael S. Sinha, Sherry H. Yu, Sherry H. Yu, Nicole R. LeBoeuf, Nicole R. LeBoeuf, Ben Linville-Engler, Ben Linville-Engler, Ben Linville-Engler, Peter K. Sorger, Peter K. Sorger, Peter K. Sorger
Published 2021-03-01

De Novo Powered Air-Purifying Respirator Design and Fabrication for Pandemic Response

by Akshay Kothakonda, Akshay Kothakonda, Lyla Atta, Lyla Atta, Deborah Plana, Deborah Plana, Deborah Plana, Ferrous Ward, Ferrous Ward, Chris Davis, Chris Davis, Avilash Cramer, Avilash Cramer, Robert Moran, Robert Moran, Jacob Freake, Jacob Freake, Enze Tian, Enze Tian, Ofer Mazor, Ofer Mazor, Pavel Gorelik, Pavel Gorelik, Christopher Van, Christopher Van, Christopher Hansen, Christopher Hansen, Helen Yang, Helen Yang, Yao Li, Yao Li, Michael S. Sinha, Michael S. Sinha, Ju Li, Ju Li, Sherry H. Yu, Sherry H. Yu, Nicole R. LeBoeuf, Nicole R. LeBoeuf, Peter K. Sorger, Peter K. Sorger
Published 2021-09-01