WASHINGTON DC (July 10, 2020) — The US Food and Drug Administration has been thoughtfully and deliberately determining the safest and most appropriate time to resume prioritized domestic-inspections of FDA-regulated facilities and other associated activities since we first announced postponement in March. The White House Guidelines for Opening Up America Again ar

WASHINGTON DC (June 18, 2020) — The US Food and Drug Administration has taken an additional step in harnessing real-world data to help inform the agency’s overall response to the COVID-19 public health emergency. The FDA is announcing its participation in the COVID-19 Diagnostics Evidence Accelerator, a multi-stakeholder collaborative project to advance the development of diagnostics.

WASHINGTON DC (June 15, 2020) — The US Food and Drug Administration (FDA) revoked the emergency use authorization (EUA) that allowed for chloroquine phosphate and hydroxychloroquine sulfate donated to the Strategic National Stockpile to be used to treat certain hospitalized patients with COVID-19 when a clinical trial was unavailable, or participation in a clinical trial was not feasibl

WASHINGTON DC (June 10, 2020) — The US Food and Drug Administration issued an emergency use authorization (EUA) to Illumina, Inc. for the first COVID-19 diagnostic test utilizing next generation sequence technology.

WASHINGTON DC (June 5, 2020) — On June 4, the US Food and Drug Administration publicly posted test performance data from four more antibody, or serology, test kits on open.fda.gov from its independent performance validation study effort with the National Institutes of Health’s (NIH) National Cancer Institute (NCI).

LENEXA, KANSAS (June 5, 2020) The US Environmental Protection Agency (EPA) issued a proposal to improve the rulemaking process under the Clean Air Act by establishing requirements to ensure consistent, high-quality analyses of benefits and costs are provided to the public for significant rules.

WASHINGTON DC (May 22, 2020) — As the nation grapples with the COVID-19 public health emergency, the US Food and Drug Administration is grateful for all that the food and agricultural sector is doing to provide safe and available food to consumers during this difficult time.

WASHINGTON DC (March 22, 2020) — The US Food and Drug Administration posted on May 21 a list of antibody tests that are being removed from the “notification list” of tests being offered under the 

WASHINGTON DC (May 20, 2020) — The US Food and Drug Administration (FDA) has announced another step in their effort to harness diverse streams of data to understand and respond to COVID-19. The FDA has entered into an agreement with Aetion to collaborate on advanced analytical techniques to answer urgent coronavirus disease (COVID-19) research questions.

WASHINGTON DC (May 12, 2020) — During COVID-19, the US Food and Drug Administration will continue to utilize and implement additional alternative inspection-tools and approaches while postponing domestic and foreign routine-surveillance inspections. This will continue as local, national, and international conditions warrant, with the exception of certain mission-critical inspections.