FDA Summary: August 19, 2022

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For immediate release:

Today, the U.S. Food and Drug Administration provides an at-a-glance summary of news from the agency:

  • Today, the FDA authorized emergency use of the Novavax COVID-19 vaccine, adjuvant for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV -2) in individuals from 12 to 17 years old. age. This clearance follows a rigorous analysis and evaluation of safety and efficacy data conducted by the FDA. The agency previously licensed the vaccine for people 18 and older. Additional information is available on the agency’s website.
  • Today, the FDA’s National Center for Toxicological Research (NCTR) announced the publication of the “Standard Test Method for the 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 Cancer Research Laboratory and later evaluated at NCTR Nanocore to become an ASTM international test method standard. International test method standards are an invaluable resource for the FDA and industry to protect and promote public health.
  • On Thursday, the FDA alerted patients, caregivers and healthcare professionals that self-injecting devices that are optional for use with glatiramer acetate injection may not be compatible for use with FDA approved glatiramer acetate injection drug products. The FDA has received reports that using an auto-injector that is not compatible with the patient’s specific glatiramer acetate injection medication has resulted in missed and partial doses. The FDA has asked drug manufacturers to update their labeling to require users to confirm that the autoinjector is compatible before using it to inject glatiramer acetate. Users can confirm compatibility by speaking with their healthcare provider or by visiting the drug manufacturer’s patient information website. Users must also confirm that the auto-injector is compatible each time they receive a new prescription for an injectable glatiramer acetate medication.
  • On Thursday, the FDA released 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 rely on scientific rigor, thoughtfulness, and adaptability to meet this challenge. The past two years have seen unprecedented progress in pandemic preparedness within the US government, particularly at the FDA.
  • On Thursday, the FDA signed a confidentiality undertaking with Ecuador’s Vice Ministry of Aquaculture and Fisheries, an important step in establishing a pilot shrimp safety program with Ecuador, a major exporter of shrimp 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 gum. The manufacturer states that each gummie contains 1mg of nicotine with 12 gummies (12mg) per box. They are available in three flavors – Blueraz, Cherry Bomb and Pineapple. The packaging claims that the products contain nicotine without tobacco. This company 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 concern to the public due to their resemblance to kid-friendly foods or candies and the potential to cause serious nicotine toxicity or even death in young children.
  • On Wednesday, the FDA updated its letter to health care providers – Stop using certain syringes and needles with needle safety devices made by Haiou. In June 2022, Guangdong Haiou Medical Apparatus Co., Ltd. initiated a voluntary recall of HAIOU Needle Retractable Safety Syringe 1mL with 23G 1 inch Needle and HAIOU Needle Retractable Safety Syringe 1mL 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 and lower the cost of hearing aid technology for millions of Americans. The final rule allows hearing aids in this category to be sold directly to consumers in stores or online without a medical examination or fitting by an audiologist. The FDA simultaneously issued a final guidance, “Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products (PSAPs)”, outlining hearing aids, PSAPs, their respective intended uses, and the regulatory requirements that apply to both types of devices. products. HHS Secretary Becerra, FDA Commissioner Robert M. Califf, CDRH Director Dr. Jeff Shuren, and National Economic Council WH Director Brian Deese hosted a media advisory call.
  • On Tuesday, the FDA released the draft guidance – Hydrogen Peroxide Contact Lens Care Products: Labeling Recommendations for Consumers – Premarket (510(k)) Notification Submissions. The draft guidelines provide labeling recommendations for hydrogen peroxide-based (HPCP) contact lens care products submitted in premarket notification (510(k)) submissions. These labeling recommendations are important because misuse associated with these devices has resulted in serious eye damage. The FDA believes that the labeling recommendations in this draft guidance, when final, will help manufacturers develop labeling that includes specific risk information and instructions for use of HPCPs in conjunction with contact lenses. prescribed to the user.
  • On Tuesday, the FDA updated its safety communication to provide the latest information on medical device reports (MDRs) received from May 1, 2022 through July 31, 2022, which are associated with the degradation of polyester-based polyurethane. (PE-PUR) foam used in Philips Respironics ventilators, BiPAP devices, and CPAP devices included in the June 2021 recall. Additionally, the FDA has taken additional action since the publication of this updated safety communication in November 2021. Updates are described in FAQ: What the FDA is Doing.
  • COVID-19 testing updates:
    • To date, 439 tests and specimen collection devices are authorized by the FDA under Emergency Use Authorizations (EUAs). These include 302 molecular tests and sample collection devices, 85 antibody tests and other immune response tests, 51 antigen tests and 1 diagnostic breath test. There are 78 molecular clearances and 1 antibody clearance that can be used with home samples. There is 1 EUA for molecular prescription home testing, 2 EUA for antigen prescription home testing, 19 EUA for over-the-counter (OTC) antigen home testing and 3 for home testing Molecular OTCs.
    • The FDA has authorized 31 antigen tests and 8 molecular tests for serial screening programs. The FDA also authorized 1,089 revisions to EUA clearances.

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The FDA, an agency of the United States Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of drugs, vaccines, and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of the food supply, cosmetics, dietary supplements, electronic radiation emitting products and the regulation of tobacco products.


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