The FDA will make all of the data and information regarding emergency use authorization it has granted to COVID-19 drugs and vaccines publicly available, the agency said Nov. 17.
The agency said the move is intended to increase public trust in the authorizations it has granted.
"Today’s transparency action is just one of a number of steps we are taking to ensure public confidence in our EUA review process for drugs and biological products, especially any potential COVID-19 vaccines," FDA Commissioner Stephen Hahn, MD, said.
All of the FDA's drug and biological product centers will share information about the scientific review and documents supporting the authorizations, as well as any revisions of revocations of the authorizations "to the extent appropriate and permitted by law."
"We will also continue to follow the science and ensure that science remains the driver of the agency’s regulatory decision-making in our fight against COVID-19 and beyond on behalf of public health," Dr. Hahn said.
Dr. Hahn added that he hopes the transparency will help healthcare providers understand the benefits, risks and proper uses of FDA-authorized products.
"Let me be clear on a crucial point — the issuance of an EUA is based on data and science. For an EUA to be authorized, FDA’s career scientists conduct a rigorous evaluation of currently available scientific evidence about a medical product," he wrote.
Read the full news release here.