Media reported that in response to the new coronavirus pandemic emergency action, many of the existing regulations have been removed to speed up the approval of the drug supply for the epidemic detection and treatment. Unfortunately, some people have taken advantage of this particular period of doing things to push products that may not have any effect at all into the FDA’s current lax approval process.
In response, the FDA has now announced that it will require companies that submit new coronavirus testing products to provide proof that their products are valid before they can bring their products to market.
In the revised policy, the FDA has the following expectations for antibody testing developers:
“Commercial manufacturers will submit the EUA request and its validation data within 10 working days from the date of notifying the FDA of its validation testing or on the date of the effective date of this policy, whichever is later.”
In addition, the FDA provides specific and sensitive threshold recommendations for all serological testing developers. “
These are obviously very good policies, especially when people start to learn more about the virus and the diseases it causes.