CDC Requires Negative COVID-19 Test for Air Travelers from U.K. to U.S.

CDC Requires Negative COVID-19 Test for Air Travelers from U.K. to U.S.

Atlanta, GA… President Trump is taking another step to protect the health of the American people by requiring air passengers arriving from the United Kingdom (U.K.) to test negative, via PCR or Antigen test, no more than 72 hours before departure from the U.K. to the United States. The public health authorities in the United […]

FDA Takes Further Steps to Confront Opioid Crisis Through Risk Evaluation and Mitigation Strategy Programs

FDA Takes Further Steps to Confront Opioid Crisis Through Risk Evaluation and Mitigation Strategy Programs

Washington, D.C…. While our efforts to combat COVID-19 remain at the forefront of our day-to-day activities, the U.S. Food and Drug Administration also continues its work on a number of important public health issues and, in particular, the opioid crisis. We remain committed to using all facets of our regulatory authority to lessen the impact […]

Overdose Deaths Accelerating During COVID-19

Overdose Deaths Accelerating During COVID-19

Washington, D.C…. Over 81,000 drug overdose deaths occurred in the United States in the 12 months ending in May 2020, the highest number of overdose deaths ever recorded in a 12-month period, according to recent provisional data from the Centers for Disease Control and Prevention (CDC). While overdose deaths were already increasing in the months […]

FDA Approves Prosthetic Implant for Above-the-Knee Amputations

FDA Approves Prosthetic Implant for Above-the-Knee Amputations

Washington, D.C…. “(Yesterday’s) approval of the OPRA Implant System expands options for prostheses for individuals who have had above-the-knee amputations and can help those who have had or may have problems with rehabilitation and have not been able to benefit from available socket prostheses,” said Capt. Raquel Peat, Ph.D., MP.H., USPHS, director of the FDA’s […]

FDA Approves First Oral Hormone Therapy for Treating Advanced Prostate Cancer

FDA Approves First Oral Hormone Therapy for Treating Advanced Prostate Cancer

Washington, D.C….“(Yesterday’s) approval marks the first oral drug in this class and it may eliminate some patients’ need to visit the clinic for treatments that require administration by a health care provider,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the […]

Remarks by Vice President Pence at a Safe and Effective Vaccine Confidence Event

Remarks by Vice President Pence at a Safe and Effective Vaccine Confidence Event

Washington, D.C…. The Vice President: Well, good morning. And thank you all for being here. I want to thank my wonderful wife, our Second Lady Karen Pence; the Surgeon General; Dr. Tony Fauci; and members of the White House Coronavirus Task Force who are joining us here today. I especially want to thank the fine […]

Coronavirus (COVID-19) Update: FDA Authorizes Antigen Test as First Over-the-Counter Fully At-Home Diagnostic Test for COVID-19

Coronavirus (COVID-19) Update: FDA Authorizes Antigen Test as First Over-the-Counter Fully At-Home Diagnostic Test for COVID-19

Washington, D.C…. Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first over-the-counter (OTC) fully at-home diagnostic test for COVID-19. The Ellume COVID-19 Home Test is a rapid, lateral flow antigen test, a type of test that runs a liquid sample along a surface with reactive molecules. The test detects fragments […]

Governor Newsom Launches “Vaccinate All 58” Campaign Based on Safety and Equity as First Vaccines Arrive to California

Governor Newsom Launches “Vaccinate All 58” Campaign Based on Safety and Equity as First Vaccines Arrive to California

Los Angeles, CA… As the first doses of the Pfizer vaccine arrive in California, Governor Gavin Newsom today launched “Vaccinate All 58”, California’s campaign for a safe, fair and equitable vaccine for all 58 counties in the state. The Governor joined Kaiser Permanente Los Angeles Medical Center, one of the first locations in the state […]

Governor Cuomo Announces First Dose of COVID-19 Vaccine Administered in U.S.

Governor Cuomo Announces First Dose of COVID-19 Vaccine Administered in U.S.

Albany, NY… Governor Cuomo: “We trust science here in New York. The federal government approved the vaccine. We then had a separate panel that also approved the vaccine and we’ve been following the science all along. I hope this gives you, and the healthcare workers who are battling this every day, a sense of security […]

FDA Approves First-of-its-Kind Intentional Genomic Alteration in Line of Domestic Pigs for Both Human Food, Potential Therapeutic Uses

FDA Approves First-of-its-Kind Intentional Genomic Alteration in Line of Domestic Pigs for Both Human Food, Potential Therapeutic Uses

Washington D.C…. Today, the U.S. Food and Drug Administration approved a first-of-its-kind intentional genomic alteration (IGA) in a line of domestic pigs, referred to as GalSafe pigs, which may be used for food or human therapeutics. This is the first IGA in an animal that the FDA has approved for both human food consumption and […]