Original Post On August 9, 2022, the Secretary of the Department of Health and Human Services (HHS) determined, pursuant to section 564 of the Federal Food, Drug, and Cosmetic (FD&C) Act, that there is a public health emergency, or a significant potential for a public health emergency, that affects, or has a significant potential to…
Read MoreOriginal Post For Immediate Release: October 07, 2022 Today, the U.S. Food and Drug Administration approved Boostrix (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed [Tdap]) for immunization during the third trimester of pregnancy to prevent pertussis, commonly known as whooping cough, in infants younger than two months of age. “Pertussis disease is…
Read MoreHead lice affect millions of children every year. Schoolchildren are commonly affected by head lice, which attach to hair and feed on human blood. “Although head lice are a year-round problem, the number of cases usually peaks during back-to-school time in the fall and again in January,” says Patricia Brown, M.D., a dermatologist at the…
Read MoreOriginal Post Summary Company Announcement Date: September 23, 2022 FDA Publish Date: September 23, 2022 Product Type: Food & Beverages Reason for Announcement: Undeclared Egg Company Name: Arcade Snacks Brand Name: Arcade Snacks Product Description: Candy Corn Company Announcement Arcade Snacks of Auburn, MA is recalling its 15 ounce packages of Candy Corn because they…
Read MoreOriginal Post For Immediate Release: September 30, 2022 Today, the U.S. Food and Drug Administration published guidance that will help provide a pathway for infant formulas operating under enforcement discretion in the U.S. to remain on the market. This will help ensure the U.S. continues diversifying its infant formula market and make families less susceptible to shocks…
Read MoreOriginal Post For Immediate Release: September 28, 2022 The U.S. Food and Drug Administration and the Veterans Health Administration (VHA) are announcing a collaboration intended to help accelerate American medical device innovation to further improve and benefit public health. Veteran Affairs’ VA Ventures Innovation Institute, located in Seattle, will host up to 12 FDA staff to foster…
Read MoreOriginal Post For Immediate Release: September 27, 2022 Today, the U.S. Food and Drug Administration updated its COVID-19 test policy to ensure continued access to tests while encouraging the transition of these important public health tools to traditional premarket review pathways. The updated policy describes the FDA’s intent to review only a small subset of…
Read MoreOriginal Post The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Product Name: Philips Respironics BiPAP A30, A40, V30, and OmniLab Advanced+ Product Models: A-Series BiPAP A30 (Ventilator) A-Series BiPAP A40 (Ventilator) A-Series BiPAP V30 (Auto…
Read MoreOriginal Post Summary Company Announcement Date: September 17, 2022 FDA Publish Date: September 19, 2022 Product Type: Drugs Reason for Announcement: Product contains benzene Company Name: Salon Technologies International Inc. Brand Name: Antica Farmacista Product Description: Ocean Citron Hand Sanitizer Company Announcement FOR IMMEDIATE RELEASE – September 16, 2022 – Orlando, Florida. Salon Technologies International. Inc.…
Read MoreOriginal Post Medtronic MiniMed 600 Series Insulin Pump System Potential Cybersecurity Risk September 20, 2022 – The FDA is alerting medical device users about a cybersecurity risk for the Medtronic MiniMed 600 Series Insulin Pump System (for example: MiniMed 630G and MiniMed 670G). There is a potential issue associated with the communication protocol for the…
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