Key takeaways: Juul Labs Inc. has agreed to pay $462 million to settle claims by six US states and the District of Columbia that it…
Posts tagged as “The US Food and Drug Administration”
Key takeaways: Drug industry leaders have expressed their disapproval of the Texas district court judge’s ruling to invalidate the FDA’s approval of the abortion medication…
This article discusses the FDA's Class I recall of certain Philips Respironics DreamStation1 CPAP machines due to incorrect or duplicate serial numbers during initial programming. Inhaling the foam from the recalled CPAP machines can cause serious injury or death, and Philips is offering a free replacement device to customers affected by the recall. The FDA is urging healthcare providers and patients to be aware of the recall and to report any adverse events or side effects related to the use of the recalled devices.
The US Food and Drug Administration (FDA) has approved an over-the-counter version of the opioid overdose reversal drug naloxone, increasing access to the lifesaving medication and providing an additional option for those who may not have access to a prescription or a pharmacy. This move is expected to reduce opioid overdose deaths throughout the country, and Dr. Scott Hadland, a pediatrician and an addiction specialist at MassGeneral Hospital for Children in Boston, believes it could save more lives. The FDA remains committed to addressing the evolving complexities of the overdose crisis.
The US Food and Drug Administration (FDA) has issued a nationwide recall for certain brands of frozen organic strawberries sold at Costco, Aldi, Trader Joe’s and other stores due to possible hepatitis A contamination. Five people have been infected with hepatitis A after eating the frozen organic strawberries, and the strain of hepatitis A causing the illnesses is genetically identical to the strain found in frozen strawberries from the Scenic Fruit Company. Consumers are urged to check their freezers for any of the recalled products and to seek medical attention if they are experiencing symptoms of hepatitis A.
The US Food and Drug Administration (FDA) is close to approving the first nation's RSV vaccine, developed by Pfizer, which has been shown to reduce the risk of illness from RSV by as much as 86%. The Vaccines and Related Biological Products Advisory Committee voted 7-4 in favor of the vaccine, despite some safety concerns. If approved, the vaccine would be the first of its kind in the US and provide a much-needed protection against RSV for older adults.
The US Centers for Disease Control and Prevention (CDC) is warning people to stop using the over-the-counter eye drops, EzriCare Artificial Tears, due to an outbreak of drug-resistant infections of Pseudomonas aeruginosa. The CDC has received reports of 55 infections in 12 states, including one fatality, and Global Pharma Healthcare is issuing a recall of the product. The FDA is continuing to investigate the source of the contamination and the CDC is urging people to seek medical attention if they have used the product and are experiencing any symptoms.
The US Food and Drug Administration has proposed a new draft guidance to set the allowable levels of lead in certain baby and toddler foods to 20 parts per billion or less. This could result in a 24-27% reduction in exposure to lead from these foods for babies and young children. The FDA is now seeking public comment on the proposed guidance to help inform their decision-making process.