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8 Feb 2024, 10:00 pm
The US Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health recently announced its intention to reclassify certain high-risk in vitro diagnostic devices (IVDs) as moderate risk, a potential first step as the agency prepares to oversee laboratory-developed tests (LDTs). [read post]
8 Feb 2024, 10:00 pm
The US Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health recently announced its intention to reclassify certain high-risk in vitro diagnostic devices (IVDs) as moderate risk, a potential first step as the agency prepares to oversee laboratory-developed tests (LDTs). [read post]
8 Feb 2024, 8:15 am
Food and Drug Administration (FDA) has issued critical updates on the recall of specific Philips Respironics CPAP, BiPAP, and ventilator machines, highlighting the serious nature of the situation with 561 deaths associated with these devices since the recall began in 2021. [read post]
7 Feb 2024, 1:20 pm
Food and Drug Administration. [read post]
6 Feb 2024, 9:05 pm
” The bipartisan commenters continued to say: “Changes in FSIS animal raising claim requirements must also be considered in consultation with the Food and Drug Administration (FDA) since a policy shift could also impact FDA regulated products (e.g., dairy and shell eggs). [read post]
6 Feb 2024, 3:58 pm
Food and Drug Administration (FDA) receives more than 100,000 U.S. reports each year associated with a suspected medication error An estimated 800,000 preventable medication‐related injuries occur every year in long‐term care facilities in the U.S. [read post]
6 Feb 2024, 3:38 pm
” Investigators from the CDC and the Food and Drug Administration are interviewing patients about what foods they ate before they became sick. [read post]
6 Feb 2024, 10:12 am
Food & Drug Administration (FDA) warned about the risk of dental problems linked to medications with the active ingredient buprenorphine, and the key ingredient in Suboxone.Suboxone is a buprenorphine and naloxone opioid addiction treatment drug made by pharma company Indivior. [read post]
5 Feb 2024, 9:07 pm
They already gained approvals from the Food and Drug Administration (FDA) and USDA’s Food Safety and Inspection Service (FSIS) for selling cultivated meat from Good Meat Inc. and Upside Foods. [read post]
31 Jan 2024, 1:15 pm
In a recent brief to the Patent Trial and Appeal Board (PTAB), Pfizer and BioNTech (Pfizer) told PTAB judges that Moderna’s dismissal of prior art listed in Pfizer’s August 2023 petition for inter partes review (IPR) of Moderna’s patent on mRNA vaccine technology is inconsistent with its declarations to the Food and Drug Administration (FDA) during the drug approval process. [read post]
31 Jan 2024, 1:15 pm
In a recent brief to the Patent Trial and Appeal Board (PTAB), Pfizer and BioNTech (Pfizer) told PTAB judges that Moderna’s dismissal of prior art listed in Pfizer’s August 2023 petition for inter partes review (IPR) of Moderna’s patent on mRNA vaccine technology is inconsistent with its declarations to the Food and Drug Administration (FDA) during the drug approval process. [read post]
31 Jan 2024, 6:30 am
Food and Drug Administration (FDA) has issued a Safety Communication advising healthcare providers to stop implanting Equinoxe Shoulder System joint replacement devices manufactured by Exactech. [read post]
31 Jan 2024, 6:30 am
Food and Drug Administration (FDA) has issued a Safety Communication advising healthcare providers to stop implanting Equinoxe Shoulder System joint replacement devices manufactured by Exactech. [read post]
31 Jan 2024, 6:30 am
Food and Drug Administration (FDA) has issued a Safety Communication advising healthcare providers to stop implanting Equinoxe Shoulder System joint replacement devices manufactured by Exactech. [read post]
31 Jan 2024, 4:43 am
The Biden administration has not said when the U.S. may resume funding. [read post]
30 Jan 2024, 9:05 pm
Food and Drug Administration, Centers for Disease Control and Prevention, and the U.S. [read post]
29 Jan 2024, 9:02 pm
Food and Drug Administration (FDA) and the UN Food and Agriculture Organization (FAO) have organized a workshop on the use of whole genome sequencing (WGS) in water and foodborne disease outbreaks in Peru this week. [read post]
29 Jan 2024, 10:47 am
The argument in Food and Drug Administration v. [read post]
28 Jan 2024, 9:07 pm
Food and Drug Administration (FDA) announced approval of Biogen's Byooviz (ranibizumab-nuna) as an interchangeable biosimilar to Genentech's Lucentis (ranibizumab injection). [read post]
28 Jan 2024, 9:01 pm
As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. [read post]
