Emergency Access Continues Post COVID-19 Pandemic
The U.S. Food and Drug Administration (FDA) plays a critical role in protecting the United States from threats such as emerging infectious diseases, including COVID-19.
On February 4, 2020, the U.S. HHS Secretary determined that there is a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens.
The COVID-19 public health emergency declared under section 319 of the Public Health Service Act in 2020 has allowed the FDA to provide important tools and flexibility to manufacturers, healthcare facilities, providers, patients, and other stakeholders.
The FDA Tweeted today a clarification that existing emergency use authorizations (EUAs) for COVID-19 products will remain in effect, and the agency may continue to issue new EUAs in the future when the criteria for issuance are met.
The FDA confirmed on January 31, 2023, it intends to issue a Federal Register notice regarding how HHS’ determination to end the COVID-19 public health emergency declared under the Act will impact the Agency’s COVID-19-related guidances and which of those guidances it is temporarily extending or letting expire.
The FDA reaffirmed today it remains committed to providing notice and information to all impacted stakeholders to ensure a smooth transition as the multi-year pandemic is reduced.
Detailed Information for all FDA issued COVID-19 EUAs, including authorizations and fact sheets, are posted at this link.