A federal judge has issued an injunction suspending the Food and Drug Administration's (FDA) approval of the abortion pill mifepristone, potentially impacting access to medication abortions nationwide. U.S. District Judge Matthew Kacsmaryk ruled that the FDA's two-decade-old approval of the drug violated a federal rule and was unlawful. The government has a week to appeal the decision, which could have far-reaching implications for abortion access in the United States.
Posts tagged as “FDA”
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.
Key takeaways: Narcan is a nasal spray that rapidly reverses the effects of an opioid overdose, and has been approved for over-the-counter sale and non-prescription…
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.
GOOD Meat has received a "no questions" letter from the FDA, indicating that the administration is satisfied that their lab-grown chicken product is safe to sell in the US. The company is now in talks with restaurants and food service companies about potential partnerships, and needs approval from the US Department of Agriculture in order to sell to consumers. If approved, GOOD Meat's lab-grown chicken would be the first of its kind to hit the market in the US, and is said to be more sustainable and healthier than traditional chicken.
The Oklahoma Supreme Court recently ruled that women have the right to an abortion when pregnancy risks their health, expanding the right to an abortion beyond medical emergency cases. The ruling is expected to be appealed to the U.S. Supreme Court, and a federal judge will decide if the FDA-approved abortion pill should be blocked across the country pending the outcome of the appeal. The outcome of the appeal could have far-reaching implications for abortion rights in the United States.
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 FDA's independent advisory committee has voted in favor of full approval of Pfizer's COVID-19 pill, Paxlovid, for the treatment of mild to moderate Covid-19 in adults at high risk for severe disease. The drug, a combination of nirmatrelvir and ritonavir, has been available under emergency use authorization since December 2021 and has been used by over 8 million people in the US. The FDA is expected to make a decision on full approval of the drug in the coming weeks.