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22 Dec 2022, 12:44 am
FDA, which held that that banning a single intended use of a specific device was inconsistent with the Federal Food, Drug, and Cosmetic Act’s (“FDC Act”) clear pronouncement that FDA cannot regulate the practice of medicine. [read post]
21 Dec 2022, 9:53 am
But a speedy and sometimes lax approval process by the Food and Drug Administration means some risky devices are cleared without clinical testing and receive limited oversight once on the market. [read post]
20 Dec 2022, 9:06 pm
Food safety was called out this year as the step-child of the Food and Drug Administration. [read post]
20 Dec 2022, 2:16 pm
At this time the Sun Hong brand mushrooms do not appear to be related to any outbreaks, according to the warning from the Food and Drug Administration. [read post]
20 Dec 2022, 1:52 pm
Finally, the omnibus includes the full President’s budget request of $5 million for the Food and Drug Administration to develop and implement new approach methodologies to replace animal testing. [read post]
20 Dec 2022, 5:00 am
Food and Drug Administration (FDA), which “regulates the sale of medical device products (including diagnostic tests) in the U.S. and monitors the safety of all regulated medical products. [read post]
18 Dec 2022, 9:01 pm
As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. [read post]
17 Dec 2022, 12:53 pm
Food and Drug Administration (FDA), the Texas Department of State Health Services, along with other state and local officials to investigate a multistate norovirus outbreak linked to raw oysters from harvest area TX 1, Galveston Bay, Texas. [read post]
16 Dec 2022, 9:04 pm
Food and Drug Administration (FDA) serves as the primary regulatory body for medical device cybersecurity. [read post]
16 Dec 2022, 1:59 pm
The federal agency is still working on getting a firm number of illnesses while it consults with state officials On Dec. 15 the Food and Drug Administration posted a warning about oysters harvested from harvest area TX 1, Galveston Bay, TX. [read post]
15 Dec 2022, 9:05 pm
As a diverse coalition of FDA stakeholders, we thank you for commissioning the Foundation’s independent expert review of the Human Foods Program in the Food and Drug Administration (FDA). [read post]
15 Dec 2022, 9:04 pm
Similarly, few details were provided by the Food and Drug Administration for an outbreak of infections from Salmonella Typhimurium for which the investigation remains open. [read post]
15 Dec 2022, 4:36 pm
Food and Drug Administration (FDA), the Texas Department of State Health Services, along with other state and local officials to investigate a multistate norovirus outbreak linked to raw oysters from harvest area TX 1, Galveston Bay, Texas. [read post]
15 Dec 2022, 8:05 am
Moreover, American horses routinely receive a wide array of medications and treatments that are expressly prohibited by the Food and Drug Administration for use at any time during the life of animals slaughtered for human consumption due to their toxicity to humans. [read post]
14 Dec 2022, 9:05 pm
Food and Drug Administration uses post-market surveillance techniques to update rules and guidance. [read post]
14 Dec 2022, 5:51 pm
In 2021, the FDA (Food and Drug Administration) issued a recall on certain Philips medical device products. [read post]
14 Dec 2022, 5:51 pm
In 2021, the FDA (Food and Drug Administration) issued a recall on certain Philips medical device products. [read post]
14 Dec 2022, 5:51 pm
In 2021, the FDA (Food and Drug Administration) issued a recall on certain Philips medical device products. [read post]
14 Dec 2022, 1:23 pm
Prior to the class period in the new lawsuit, the company allegedly had said that it intended to seek Emergency Use Authorization (EUA) from the Food and Drug Administration (FDA) in the second quarter of 2021. [read post]
14 Dec 2022, 8:37 am
And members of Congress, the White House, and top federal bureaucrats already may be dodging a desperately needed reckoning for the Food and Drug Administration. [read post]
