FDA News Release
FDA Roundup: August 19, 2022
- 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 authorized the emergency use of Novavax COVID-19 Vaccine, Adjuvanted for the prevention of Coronavirus Disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 through 17 years of age. This authorization follows a rigorous analysis and evaluation of the safety and effectiveness data conducted by the FDA. The agency previously authorized the vaccine for individuals 18 years and older. Additional information is available on the agency’s web site.
- Today, the FDA’s National Center for Toxicological Research (NCTR) announced the publication of the “Standard Test Method for Detection of Nitric Oxide Production In Vitro” by ASTM International. The in vitro immunology protocol was originally developed by the Nanotechnology Characterization Laboratory at the Frederick National Laboratory for Cancer Research and further evaluated at the NCTR Nanocore to develop into an ASTM International test method standard. International test method standards are an invaluable resource for both FDA and industry to protect and promote public health.
- On Thursday, the FDA alerted patients, caregivers, and health care professionals that autoinjector devices that are optional for use with glatiramer acetate injection may not be compatible for use across FDA-approved glatiramer acetate injection drug products. The FDA has received reports that using an autoinjector that is not compatible with the patient’s specific glatiramer acetate injection drug product has resulted in missed and partial doses. The FDA has requested that drug product manufacturers update their labeling to instruct users to confirm the autoinjector is compatible before using it to inject glatiramer acetate. Users can confirm compatibility by speaking with their health care provider or visiting the drug manufacturer's patient information website. Users should also confirm that the autoinjector is compatible each time they receive a new prescription for a glatiramer acetate injection drug product.
- On Thursday, the FDA issued the report: “FDA’s Work to Combat the COVID-19 Pandemic,” which outlines much of the broad range of work the FDA is undertaking to combat the COVID-19 pandemic and prepare for future emergencies. The FDA continues to build on the foundation of scientific rigor, thoughtfulness, and adaptability in rising to this challenge. The past two years have seen unprecedented progress in pandemic preparedness across the U.S. government, particularly at the FDA.
- On Thursday, FDA signed a confidentiality commitment with Ecuador’s Vice Ministry of Aquaculture and Fisheries, an important step in establishing a shrimp safety pilot program with Ecuador, a major shrimp exporter to the United States.
- On Thursday, the FDA issued a warning letter to VPR Brands LP (doing business as, “Krave Nic”), for marketing illegal flavored nicotine gummies. The manufacturer states that each gummy contains 1 mg of nicotine with 12 gummies (12 mg) per tin. They are available in three flavors – Blueraz, Cherry Bomb and Pineapple. The packaging claims that the products contain tobacco-free nicotine. This firm has not submitted a premarket tobacco product application (PMTA) to the FDA and does not have marketing authorization to manufacture, sell, or distribute these products in the United States. These types of gummies are of particular public concern because of their resemblance to kid-friendly food or candy products and the potential to cause severe nicotine toxicity or even death among young children.
- On Wednesday, the FDA updated its Letter to Health Care Providers - Stop Using Certain Syringes and Needles with Needle Safety Devices Manufactured by Haiou. In June 2022, Guangdong Haiou Medical Apparatus Co., Ltd. initiated a voluntary recall of the HAIOU Needle Retractable Safety 1 mL syringe with 23G 1-inch needle and the HAIOU Needle Retractable Safety 1 mL syringe with 25G 1-inch needle for device failure.
- On Tuesday, the FDA issued a press release announcing the final rule establishing a new category of over-the-counter hearing aids intended to improve access to and expected to reduce the cost of hearing aid technology for millions of Americans. The final rule allows hearing aids within this category to be sold directly to consumers in stores or online without a medical exam or a fitting by an audiologist. The FDA concurrently issued a final guidance, "Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products (PSAPs)," describing hearing aids, PSAPs, their respective intended uses and regulatory requirements that apply to both types of products. HHS Secretary Becerra, FDA Commissioner Robert M. Califf, CDRH Director Dr. Jeff Shuren, and WH Director of the National Economic Council Brian Deese, hosted a media advisory call.
- On Tuesday, the FDA issued the draft guidance – Hydrogen Peroxide-Based Contact Lens Care Products: Consumer Labeling Recommendations - Premarket Notification (510(k)) Submissions. The draft guidance provides labeling recommendations for hydrogen peroxide-based contact lens care products (HPCPs) submitted in premarket notification (510(k)) submissions. These labeling recommendations are important because misuse associated with these devices has resulted in serious eye injuries. FDA believes that the labeling recommendations in this draft guidance, when final, will help manufacturers develop labeling with information about specific risks and directions for use of the HPCPs in conjunction with a user’s prescribed contact lenses.
- On Tuesday, the FDA updated its safety communication to provide the latest information about medical device reports (MDRs) received from May 1, 2022, to July 31, 2022, that are associated with the breakdown of the polyester-based polyurethane (PE-PUR) foam used in the Philips Respironics ventilators, BiPAP machines, and CPAP machines included in the June 2021 recall. In addition, the FDA has taken additional actions since this updated safety communication was issued in November 2021. The updates are described in the FAQs: What the FDA is Doing.
- COVID-19 testing updates:
- As of today, 439 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 302 molecular tests and sample collection devices, 85 antibody and other immune response tests, 51 antigen tests, and 1 diagnostic breath test. There are 78 molecular authorizations and 1 antibody authorization that can be used with home-collected samples. There is 1 EUA for a molecular prescription at-home test, 2 EUAs for antigen prescription at-home tests, 19 EUAs for antigen over-the-counter (OTC) at-home tests, and 3 for molecular OTC at-home tests
- The FDA has authorized 31 antigen tests and 8 molecular tests for serial screening programs. The FDA has also authorized 1089 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