FDA Roundup: February 24, 2023

SILVER SPRING, Md., Feb. 24, 2023 /PRNewswire/ -- Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: 

• Today, the FDA published the FDA Voices: "The Work of FDA Continues in Thousands of Workstreams that Americans and the World Count on Every Day," by Robert M. Califf, M.D., Commissioner of Food and Drugs. In the second of a two-part series, Dr. Califf reflects on his one-year anniversary back at the agency and shares his vision for the future of the agency. Dr. Califf expresses his appreciation to agency staff for their hard work in such an extraordinary time and looks forward to a productive and engaging year in which the agency thrives.
  
  
• On Thursday, the FDA published the FDA Voices: "What FDA's Foods Program Achieved in 2022 to Protect Consumers and the Food Supply," by Frank Yiannas, Deputy Commissioner for Food Policy and Response, Susan T. Mayne, Ph.D., Director of the Center for Food Safety and Applied Nutrition and Judy McMeekin, Pharm.D., Associate Commissioner for Regulatory Affairs. Despite being a challenging year, the FDA's Foods Program took important strides in 2022 to protect the safety of human foods and expand access to safe and nutritious foods for all consumers.
  
  
• On Thursday, the FDA published the FDA Voices: "FDA Continues Important Work to Advance Medical Products for Patients with Rare Diseases," by Robert M. Califf, M.D., Commissioner of Food and Drugs and Sandy Retzky, D.O., J.D., M.P.H., Director, Office of Orphan Products Development. Rare Disease Week is observed during the last week of February. The agency will host its virtual Rare Disease Day on Monday, Feb. 27, 2023. The goal of this year's Rare Disease Day is to explore ways to engage and collaborate with patients and patient advocates to support the development of medical products for rare diseases.
  
  
• On Thursday, the FDA issued a letter to health care providers informing health care providers and facilities about the potential for exposure to airborne chemicals that may be released from neonatal incubators. The FDA is evaluating published literature that reports elevated levels of formaldehyde, cyclohexanone and other volatile chemicals (such as human-made chemicals used and produced in manufacturing) from neonatal incubators. Potential sources of these airborne chemicals include materials used to make neonatal incubators as well as natural and human-made sources external to the incubator. The FDA is working with manufacturers of neonatal incubators to collect and evaluate data from their products to determine whether these airborne chemicals are released, and if so, the amount of exposure and the potential risks to health from such exposure, if any, for newborns and others (such as health care providers). Currently, the FDA is not aware of any reported adverse events related to the use of neonatal incubators and exposure to these airborne chemicals.
  
  
• On Wednesday, the FDA announced that it will co-host a virtual public meeting with the Environmental Protection Agency's (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) on March 22, 2023. Additionally, EPA opened a docket for the agencies to receive public comment on their current approach to the oversight of various products regulated as either pesticides by EPA or new animal drugs by FDA, with a focus on parasite treatment products applied topically to animals and in genetically engineered pest animals for use as pest control tools. The agencies also released a document entitled, "WHITEPAPER: A Modern Approach to EPA and FDA Product Oversight," for public comment, which describes the current challenges and highlights the potential benefits of a modernized approach to oversight of these products.
  
  
• On Friday, the FDA issued an emergency use authorization (EUA) for the GenBody COVID-19 Ag Home Test (manufactured by GenBody, Inc.) and on Wednesday, February 22, the FDA issued an EUA for COVI-Go-SARS-CoV-2 Ag Self Test (manufactured by Mologic, Inc.). Validation data to support the EUAs of these tests were gathered through the National Institutes of Health (NIH) Independent Test Assessment Program (ITAP), established as a collaboration between the FDA and the NIH. Both tests can be used for serial testing for symptomatic people within the first 5 days of symptom onset or for people who do not have symptoms. The GenBOdy COVID-19 Ag Home Test shows results in 15 minutes, and the COVI-Go-SARS-CoV-2 Ag Self Test shows results in 20 minutes. These tests should always be repeated if a negative result is found - at least 2 times over 3 days with at least 48 hours between tests if the person has symptoms, or at least 3 times over 5 days with at least 48 hours between tests if the person does not have symptoms. The tests can be used for people age 14 years or older with a self-collected nasal swab sample and age 2 years or older when an adult collects the nasal swab sample.
  
  
• COVID-19 testing updates:
  
  
• As of today, 443 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 298 molecular tests and sample collection devices, 84 antibody and other immune response tests, 60 antigen tests, and one diagnostic breath test. There are 78 molecular authorizations and one antibody authorization that can be used with home-collected samples. There is one EUA for a molecular prescription at-home test, two EUAs for antigen prescription at-home tests, 28 EUAs for antigen over-the-counter (OTC) at-home tests, and four for molecular OTC at-home tests.
• The FDA has authorized 45 antigen tests and eight molecular tests for serial screening programs. The FDA has also authorized 1254 revisions to EUA authorizations.

 Additional Resources: 

• FDA Newsroom

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Media Contact: FDA Office of Media Affairs, 301-796-4540 
Consumer Inquiries: 888-INFO-FDA 

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. 

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SOURCE U.S. Food and Drug Administration