The FDA announced on October 7 that it will no longer review requests for Emergency Use Authorizations (EUAs) for COVID-19 laboratory developed tests – so called “LDTs.” This is a substantial change in Agency policy.
From...more
In the Food and Drug area, we don’t often get dramatic changes in FDA policies, but an announcement from the Secretary of HHS, published on August 18, appears to be just such a dramatic change.
In the new announcement, HHS...more