- For Immediate Release:
Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:
- Today, the FDA issued an emergency use authorization (EUA) for the Azure Fastep COVID-19 Antigen Pen Home Test (manufactured by Azure Biotech, Inc.). Validation data to support the EUA of this test was gathered through the National Institutes of Health (NIH) Independent Test Assessment Program (ITAP), established as a collaboration between the FDA and the NIH. The test can be used for serial testing for symptomatic people within the first 6 days of symptom onset or for people who do not have symptoms and shows results in 15 minutes. This test 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 test can be used for people aged 14 years or older with a self-collected nasal swab sample and aged 2 years or older when an adult collects the nasal swab sample.
- On Thursday, the FDA issued a final order to modify the yogurt standard of identity final rule, published on June 9, 2021. The FDA is denying the International Dairy Foods Association’s (IDFA) request for a public hearing and is issuing a final order to modify the final rule with respect to maximum pH. The FDA is amending the yogurt standard acidity requirement to require products to have a pH of 4.6 or lower. This will ensure the safety of yogurt, while maintaining its basic nature and essential characteristics.
- On Thursday, the FDA issued a letter to developers and manufacturers who intend to transfer genes for proteins that are food allergens into new plant varieties used for food, reminding them of the relevant legal requirements and potential food safety concerns related to these products and encouraging developers to consult with us prior to marketing. The FDA is not aware of any foods currently in the U.S. market from these types of new plant varieties, but we are aware of research and development in this area.
- On Thursday, the FDA issued a Drug Safety Communication announcing several updates to the prescribing information for immediate-release and extended-release/long-acting opioid analgesics. The updates also include a new warning about opioid-induced hyperalgesia, which is a condition where opioids cause an increase in pain (hyperalgesia) or an increased sensitivity to pain (allodynia).
- On Wednesday, the FDA advised consumers that hand sanitizers are regulated as over-the-counter (OTC, or nonprescription) drugs. If you use alcohol-based hand sanitizers, read and follow the Drug Facts label, particularly the warnings section, and keep these safety tips in mind.
- On Wednesday, the FDA published a webinar titled Modernization of Cosmetics Regulation Act of 2022 – Key Terms and Provisions. This stakeholder webinar provides an overview of the Modernization of Cosmetics Regulation Act of 2022. It outlines the requirements mandated by the act, also known as MoCRA, and the current steps FDA is taking to implement the requirements, including an update on the Voluntary Cosmetic Reporting Program and information about the upcoming public listening session on good manufacturing practices (GMPs).
- On Wednesday, the FDA published “Catching Up with Califf:” “FDA is Working to Combat the Epidemic of Diet-Related Chronic Disease through our Nutrition Efforts,” by Robert M. Califf, M.D., Commissioner of Food and Drugs. In part 3 of this series on food, Dr. Califf discusses nutrition, a priority area of work at the FDA. Focusing more on nutrition gives us the real opportunity to significantly improve public and individual health. The agency is committed to finding new ways to help reduce the burden of diet-related chronic disease through improved information about wise nutritional choices given our unique position and authorities.
- On Wednesday, the FDA issued a safety communication recommending consumers, health care providers, and facilities to not use certain surgical N95 respirators by O&M Halyard and to use caution with certain surgical masks and pediatric face masks by O&M Halyard. The FDA is aware of laboratory test results that show certain models of O&M Halyard surgical N95 respirators, surgical masks, and pediatric face masks do not meet quality and performance expectations and may not provide expected fluid barrier protection to the wearer. The FDA is continuing its evaluation.
- On Wednesday, the FDA issued a draft guidance for industry titled Over-the-Counter Monograph Order Requests (OMORs): Format and Content. This guidance provides the FDA’s recommendations on the format and content of the information that requestors should provide in an OMOR and identifies relevant guidance documents to assist requestors in preparing their OMORs. The draft guidance gives an overview of the information the agency may recommend for a sufficiently complete OMOR.
- On Tuesday, the FDA announced a Radiation Sterilization Master File Pilot Program. The pilot program is voluntary and intended to allow companies that sterilize single-use, PMA-approved medical devices using gamma radiation or ethylene oxide (EtO) to submit master files when making certain changes to sterilization sites, sterilization methods, or other processes, for example, lowering the gamma radiation dose. The FDA is seeking up to nine companies to be part of the voluntary pilot program. The program seeks to help companies advance alternative and innovative ways to sterilize approved medical devices, including changing radiation sources, in a least burdensome regulatory approach. You can read the CDRH statement here.
- This week, the FDA’s Center for Drug Evaluation and Research (CDER) published a CDER Conversation titled, Using Innovative Communication Methods to Increase Awareness and Understanding of CDER Guidance Documents: CDER’s Guidance Snapshot Pilot Program. The Guidance Snapshot Pilot Program communicates guidance recommendations to multiple stakeholder audiences using visuals, plain language, and other innovative technologies to increase awareness and understanding of CDER’s often complex guidance documents. In the CDER Conversation, ShaAvhrée Buckman-Garner, M.D., PhD., director of CDER’s Office of Translational Sciences, and James-Denton Wyllie, director of CDER Office of Communications, discuss the Guidance Snapshot Pilot Program and why their offices partnered to help educate stakeholders and increase public awareness of guidance documents.
- The FDA will be hosting a virtual public meeting titled Good Manufacturing Practices for Cosmetic Products Listening Session on June 1, 2023 from 10 am to 1 pm EDT. The purpose of the listening session is to consult cosmetics manufacturers, including smaller businesses and contract manufacturers, consumer organizations, and other experts to inform Agency efforts to develop regulations to establish good manufacturing practices for facilities that manufacture, or process, cosmetic products distributed in the United States.
- Additional meeting specifics, including information on how to register for the meeting, will be made available soon through a Federal Register Notice, and at https://www.fda.gov/cosmetics/cosmetics-news-events/meetings-conferences-workshops-cosmetics.
- COVID-19 testing updates:
- As of today, 446 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 300 molecular tests and sample collection devices, 84 antibody and other immune response tests, 61 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 five for molecular OTC at-home tests.
- The FDA has authorized 46 antigen tests and eight molecular tests for serial screening programs. The FDA has also authorized 1348 revisions to EUA authorizations.
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.
- FDA Office of Media Affairs