Public health emergency response and other updates from FDA since our last email update include:

• May 16, 2023: FDA Roundup including an update to the web page Rumor Control
• May 12, 2023: FDA Roundup including updated information on medical device shortages
• May 12, 2023: Eleventh Amendment to Declaration Under the PREP Act for Medical Countermeasures Against COVID-19 (HHS Federal Register notice)
• May 11, 2023: FDA Voices: Lessons Learned from COVID-19 Are Informing Preparation for Future Public Health Emergencies
• May 11, 2023: FDA Commissioner Dr. Robert Califf and other HHS officials testified at a U.S. House Energy & Commerce Health Subcommittee hearing, Preparing for and Responding to Future Public Health Security Threats
• May 10, 2023: FDA Releases Two Discussion Papers to Spur Conversation about Artificial Intelligence and Machine Learning in Drug Development and Manufacturing
• May 9, 2023: From HHS: Fact Sheet: End of the COVID-19 Public Health Emergency
  

Quick links: COVID-19 updates from FDA, FDA Mpox Response 

On May 11, 2023, the COVID-19 public health emergency (PHE) declared under the Public Health Service Act expired. While the PHE has ended, people are still getting sick from COVID-19, and the virus remains a leading cause of death in the United States. CDC continues to advise that everyone get vaccinated, get an additional vaccine dose if your doctor advises it, use at-home tests if you’ve been exposed or have symptoms, stay home if you’re sick, and wear a high-quality mask when COVID-19 community levels are high. These precautions are the best ways you can protect yourself and your loved ones.

FDA is committed to continuing to use every tool in our toolbox to fight COVID-19, including pivoting as the virus adapts. We’ll continue to post the latest updates at: http://www.fda.gov/covid19.

Consumer resources

• Know Your Treatment Options for COVID-19
• COVID-19 Vaccines
• Beware of Fraudulent Coronavirus Tests, Vaccines and Treatments
• Understanding the Regulatory Terminology of Potential Preventative and Therapeutic Drugs for COVID-19

FDA Voices, by Robert M. Califf, M.D., Commissioner of Food and Drugs and Hilary Marston, M.D., M.P.H., Chief Medical Officer

As we reflect on the devastating losses and lasting impacts the COVID-19 pandemic has had worldwide, we will use the lessons we’ve learned to be thoughtful about preparing for future public health emergencies and use the knowledge gained from our experience with COVID-19 to inform our future response efforts. (May 11, 2023)