Search for: "U.S. Food and Drug Administration"
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21 Jul 2023, 9:03 pm
The Food and Drug Administration is continuing its use of import alerts to enforce U.S. food safety regulations for food from foreign countries. [read post]
21 Jul 2023, 9:01 am
Food and Drug Administration (FDA) as breakthrough devices.[1] As described in the notice with comment period (the “Procedural Notice”), the voluntary TCET pathway aims to streamline efforts between CMS, the FDA, and manufacturers of certain FDA-designated breakthrough devices to more efficiently advance breakthrough devices through the CMS coverage determination processes using a “coverage with evidence development” (CED) approach. [read post]
19 Jul 2023, 9:04 pm
Food and Drug Administration and Laura Gieraltowski, from the U.S. [read post]
19 Jul 2023, 5:42 pm
Food and Drug Administration are investigating an outbreak of hepatitis A linked to frozen organic strawberries imported from certain farms located in Baja California, Mexico, by a common supplier. [read post]
19 Jul 2023, 5:04 pm
Food and Drug Administration, as well as the U.S. [read post]
18 Jul 2023, 11:45 am
Food and Drug Administration Adverse Event Reporting System Public Dashboard, there have been at least 60 reports of suicidal ideation since 2018 from patients on semaglutide or their health care providers. [read post]
16 Jul 2023, 9:03 pm
Food and Drug Administration has issued a response to the recent assessments. [read post]
15 Jul 2023, 8:06 am
The US Food and Drug Administration (FDA) is advising consumers not to eat, and restaurants and food retailers not to sell, and to dispose of raw oysters that were harvested from harvest location NS 10 in Nova Scotia, Canada on June 9, 2023 and were distributed to 17 states and the District of Columbia: CA, CO, CT, DC, DE, FL, GA, IN, MA, MD, MI, MN, NJ, NY, OH, PA, TX, and WI. [read post]
14 Jul 2023, 2:20 pm
The Food and Drug Administration reported that the oysters were harvested in Nova Scotia. [read post]
14 Jul 2023, 11:10 am
Food and Drug Administration (FDA) in 2002. [read post]
14 Jul 2023, 7:53 am
Food and Drug Administration (FDA), the agency responsible for protecting participants in commercial drug trials, is not a signatory to the Common Rule, Congress has required that the FDA harmonize the protection it offers participants so that it is as least as strong as the Common Rule. [read post]
13 Jul 2023, 9:16 pm
Food and Drug Administration (FDA) approved the first oral contraceptive available in the United States without a prescription. [read post]
13 Jul 2023, 5:26 pm
Food and Drug Administration (FDA) investigated a multistate outbreak of Salmonella Enteritidis infections. [read post]
12 Jul 2023, 7:50 pm
Food and Drug Administration approved Opill (norgestrel) tablet for nonprescription use to prevent pregnancy— the first daily oral contraceptive approved for use in the U.S. without a prescription. [read post]
11 Jul 2023, 9:04 pm
Food and Drug Administration; Dr. [read post]
10 Jul 2023, 9:05 pm
Food and Drug Administration along with the Centers for Disease Control and Prevention are investigating at least four other outbreaks of cyclospora infections. [read post]
10 Jul 2023, 9:00 pm
The Food and Drug Administration is continuing its use of import alerts to enforce U.S. food safety regulations for food from foreign countries. [read post]
10 Jul 2023, 5:58 am
While xylazine never received approval by the United States Food and Drug Administration (“FDA”) for use in humans, the drug has been approved by the FDA for use in veterinary medicine since 1972. [read post]
9 Jul 2023, 9:05 pm
Food and Drug Administration, and manufacturers must secure distribution networks to get drugs to pharmacies and patients. [read post]
7 Jul 2023, 2:06 pm
Blackburn 22-1180Issue: Whether a state-law claim is preempted if it places a duty on a drug manufacturer to unilaterally change language approved by the Food and Drug Administration that appears in the highlights section of a drug label. [read post]
