Day: April 9, 2020

In about 3 weeks since FDA announced a policy under which serological tests could be sold with just a notification of intent to file an EUA, more than 70 companies have filed this notification and started selling diagnostic tests that measure anti-coronavirus antibodies. However, these tests must carry a disclaimer that the test has not … Read more

In the last two months, FDA has announced, proposed, and implemented several measures to address the ongoing pandemic, but questions are being raised about the perceived slow speed at which FDA acts in an emergency. There have been complaints of FDA taking too long to authorize diagnostic tests and making decisions on the Emergency Use … Read more