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24 Mar 2020, 6:32 am
In conjunction with the new report on root cause analysis, Pew also released a Question and Answer session with Frank Yiannas, deputy commissioner for food policy and response. at the Food and Drug Administration (FDA). [read post]
23 Mar 2020, 9:03 pm
Food and Drug Administration if they want a piece of the U.S. market, and once again foreign food producers outnumber the domestic ones. [read post]
23 Mar 2020, 7:35 pm
The company, Guan’s Mushroom Co. of Commerce, CA, is recalling all cases of its 200-gram/7.05-ounce packages of enoki mushrooms, according to a recall notice posted by the Food and Drug Administration. [read post]
23 Mar 2020, 4:21 pm
Step 2: Monitoring the System The Marchand opinion also indicates that even where a company is complying with applicable law and regulations, e.g., Food and Drug Administration, such compliance does not imply that the board has implemented a monitoring system at the board level.[12] In other words, Delaware courts will evaluate (i) what systems the board implements, aside from mandatory regulations, in order to stay informed and ensure that the company is operating… [read post]
23 Mar 2020, 1:28 pm
Finally, in a speech at the Medicare Prescription Drug Plan Spring Conference, Seema Verma, Administrator, CMS, stated that “[t]his means that now Medicare Advantage beneficiaries will be provided adult day care services, respite care for caregivers, and in-home assistance with activities like bathing and managing medications. [read post]
23 Mar 2020, 9:03 am
The Federal Trade Commission (“FTC”) announced its settlement with NeuroMetrix, Inc. over allegations that the company made deceptive claims that its nerve stimulation device called Quell, which is to be worn just below the knee, treats pain throughout the body and is clinically proven and cleared by the Food and Drug Administration (“FDA”) to do so. [read post]
23 Mar 2020, 9:03 am
The Federal Trade Commission (“FTC”) announced its settlement with NeuroMetrix, Inc. over allegations that the company made deceptive claims that its nerve stimulation device called Quell, which is to be worn just below the knee, treats pain throughout the body and is clinically proven and cleared by the Food and Drug Administration (“FDA”) to do so. [read post]
23 Mar 2020, 5:35 am
The Secretary also designated persons authorized to “prescribe, administer, deliver, distribute or dispense the Covered Countermeasures, and their officials, agents, employees, contractors and volunteers” and those “authorized to perform an activity under an Emergency Use Authorization” under the Federal Food, Drug, and Cosmetic Act. [read post]
22 Mar 2020, 9:01 pm
As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. [read post]
21 Mar 2020, 9:01 pm
I’ve been plenty critical of the premier federal agencies like the Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA) and USDA. [read post]
20 Mar 2020, 2:07 pm
As the effects of coronavirus continue to ripple across the globe, the Federal Trade Commission (FTC) and Food and Drug Administration (FDA) have warned seven companies for purportedly “making deceptive or scientifically unsupported claims about their ability to treat coronavirus (COVID-19). [read post]
20 Mar 2020, 1:34 pm
It wasn't until the end of February that the Food and Drug Administration opened the door for a wide range of organizations to offer coronavirus tests. [read post]
20 Mar 2020, 9:32 am
Food and Drug Administration (“FDA”) and the Federal Trade Commission (“FTC”) issued warning letters to seven companies allegedly selling unapproved products that may violate federal law by making deceptive or scientifically unsupported claims about their ability to treat coronavirus (COVID-19). [read post]
20 Mar 2020, 9:32 am
Food and Drug Administration (“FDA”) and the Federal Trade Commission (“FTC”) issued warning letters to seven companies allegedly selling unapproved products that may violate federal law by making deceptive or scientifically unsupported claims about their ability to treat coronavirus (COVID-19). [read post]
20 Mar 2020, 9:22 am
Be aware of the risk of drug/drug or drug/food interactions. [read post]
19 Mar 2020, 9:05 pm
District Court for the District of Columbia temporarily blocked a rule that would have placed new restrictions on the federal government’s food assistance program, known as SNAP. [read post]
19 Mar 2020, 7:39 pm
Food and Drug Administration has issued its most serious type of recall, a Class I recall, for two models of Medtronic MiniMed 600 Series insulin pumps. [read post]
19 Mar 2020, 2:47 pm
The Food and Drug Administration (FDA) has traced the outbreak to sprouts grown by Chicago Indoor Garden, and possibly other growers. [read post]
18 Mar 2020, 9:05 pm
Court of Appeals to review a Food and Drug Administration (FDA) decision to approve soy leghemoglobin as a color additive for use in ground beef analog products. [read post]
18 Mar 2020, 9:02 pm
Food and Drug Administration (FDA) recently issued unprecedented guidance to increase the availability of diagnostic tests. [read post]
