Newsletter - May 28, 2020
Meetings with FDA, As You Have Known, May be History
FDA announced this week that it will no longer hold in-person meetings. All previously scheduled in-person meetings have been converted to phone meetings or written responses only. Many meeting requests will be delayed and may be denied. Among the impacts of the pandemic, this change will perhaps...Read More
In the Race for Home-Based Rapid COVID Tests, Antibody Tests Show Promise
Tests that detect antibodies to the coronavirus in blood, serum and plasma have emerged as the key players in creating a feel-safe environment for re-opening our lives post-pandemic, and present an interesting safety and effectiveness paradigm for regulatory agencies. Antibody detecting tests can be designed to give results...Read More
Meetings with FDA, As You Have Known, May be History
FDA announced this week that it will no longer hold in-person meetings. All previously scheduled in-person meetings have been converted to phone meetings or written responses only. Many meeting requests will be delayed and may be denied. Among the impacts of the pandemic, this change will perhaps...Read More
In the Race for Home-Based Rapid COVID Tests, Antibody Tests Show Promise
Tests that detect antibodies to the coronavirus in blood, serum and plasma have emerged as the key players in creating a feel-safe environment for re-opening our lives post-pandemic, and present an interesting safety and effectiveness paradigm for regulatory agencies. Antibody detecting tests can be designed to give results...Read More
