The U.S. Food and Drug Administration (FDA) drug and biological product centers intend, to the extent appropriate and permitted by law, to publicly post their reviews of the scientific data and information supporting the issuance, revision, or revocation of Emergency Use Authorizations (EUAs) for all drug and biological products, including vaccines, as part of the agency’s broader COVID-19 response, FDA Commissioner Stephen Hahn announced yesterday (November 17).
“We have already posted some scientific review documents, for instance for an EUA revocation as well as an EUA authorization, and we are committing to continuing to post these documents moving forward,” Hahn said.
EUAs are an important tool in our country’s fight against COVID-19 and other public health emergencies, Hahn noted. While EUAs have received increased attention during the COVID-19 public health emergency, they are not a new tool to the FDA, he added. He stressed “FDA’s commitment to [maintaining] transparency around the EUA process and [sharing] some updates on our plan to provide more information about FDA’s decisions” regarding EUAs.
Innovation in the Era of COVID—ACRP 2021 Starts in January
Unlock your potential by learning innovative new ways clinical research is being conducted in response to COVID-19. This online, interactive program features FDA officials and industry experts who will address telemedicine, remote monitoring, team management, study start-up, and more in the era of COVID.
Special Offer! Get the entire program—including 24 ACRP Contact Hours—for just $299 through December 31.
Earlier this year, the FDA launched the COVID-19 Pandemic Recovery and Preparedness Plan (PREPP) to help apply best practices and lessons learned from the emergency response to date. The goal is to optimize the ongoing COVID-19 response, while also strengthening agency resilience and improving its capacity to respond to future public health emergencies.
“In particular, we recognize that disclosing information from the scientific review documents supporting the issuance, revision, or revocation of EUAs…will contribute to the public’s confidence in the agency’s rigorous review of scientific data and the appropriate use of authorized products,” Hahn said.
Edited by Michael Causey