FDA

FDA expands on 2 coronavirus treatment trials

FDA expands on 2 coronavirus treatment trials

The FDA announced expansions of clinical trials and potential for expanded access programs for two treatments for COVID-19. The FDA announced this latest national effort to bring blood-related therapies for the novel coronavirus (COVID-19) global pandemic this afternoon. The two potential treatment products are called convalescent plasma and hyperimmune globulin.

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That 2-minute coronavirus test FDA approval was a “misunderstanding”

That 2-minute coronavirus test FDA approval was a “misunderstanding”

After claiming they'd received FDA authorization for a 2-minute coronavirus antibody test earlier this week, a company called Bodysphere just changed their tune. They made clear in their press release released at the tail end of March, 2020, that the Food and Drug Administration had approved their coronavirus (COVID-19) testing kit. It all seemed too good to be true. Turns out, it was.

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FDA says throw this popular heartburn medicine away over cancer risk

FDA says throw this popular heartburn medicine away over cancer risk

A popular heartburn drug has been yanked from shelves, and the FDA has warned it should be thrown out of medicine cabinets, after testing revealed that it could contain a cancer-causing carcinogen. While the US Food and Drug Administration says it only discovered dangerous levels of NDMA in a small number of samples, it's enough to warrant a complete lock-down on production.

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FDA reportedly approves two-minute coronavirus antibody testing kit [Update: Hoax?]

FDA reportedly approves two-minute coronavirus antibody testing kit [Update: Hoax?]

The Food and Drug Administration has approved a coronavirus testing kit from Bodysphere, one that can detect antibodies related to the virus in only two minutes, the company announced today. The test will be deployed in states around the country, enabling healthcare facilities to test for signs that the patient had contracted the virus at some point. The testing kit is only intended for use by medical professionals, however. [Update: This announcement could well be a hoax, it's been reported; see the update at the end of the article]

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FDA approves Battelle tech for decontaminating N95 respirators

FDA approves Battelle tech for decontaminating N95 respirators

An important type of face mask called an N95 respirator is in critically short supply at the moment, putting medical workers in many countries at risk of contracting the novel coronavirus. Unlike surgical masks and ordinary paper masks, an N95 respirator features a tight fit and can filter out the majority of particles in the air. In light of the shortage, the FDA has granted emergency use authorization to new technology that can decontaminate used N95 respirators.

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FDA: Don’t blame us for coronavirus test “roadblock”

FDA: Don’t blame us for coronavirus test “roadblock”

The FDA is pushing back at accusations that it has been a bottleneck in coronavirus testing, dismissing criticisms that COVID-19 specific tests have been delayed because of its oversight. US testing numbers amid the coronavirus pandemic have become a topic of huge controversy in recent weeks, with suggestions that uncertainty about just how many Americans might be infected have left healthcare providers floundering and unprepared.

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Mushroom recall expands as another company pulls all products

Mushroom recall expands as another company pulls all products

Following an initial announcement earlier this month, the FDA has published a new food safety advisory warning that another large batch of a popular type of mushroom called enoki has been recalled. As with the initial recall, these latest recalled mushrooms originate from South Korea and may cause a foodborne illness caused by the bacteria Listeria monocytogenes.

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FDA says popular dried fish treats for pets recalled over botulism risk

FDA says popular dried fish treats for pets recalled over botulism risk

In an announcement on Monday, the FDA revealed that popular, organic pet food treats made out of fish have been recalled out of 'an abundance of caution' over potential botulism risk. The reason is due to the fish used to make the treats -- they were larger than what is allowed by FDA guidelines, which exist to help protect against botulism poisoning in humans.

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Temporary FDA policy helps doctors monitor COVID-19 patients at home

Temporary FDA policy helps doctors monitor COVID-19 patients at home

As hospitals prepare for what is expected to be a very high number of COVID-19 patients in coming weeks, the FDA has revealed a new policy that allows certain non-invasive medical equipment to be used for remotely monitoring patients. The idea is that someone who has a health issue that requires monitoring, but who can safely remain home, is better off being monitored from a distance rather than being exposed to overcrowded health facilities.

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FDA takes drastic step to get hand sanitizer on sale again

FDA takes drastic step to get hand sanitizer on sale again

Two new bits of Guidance were released today by the FDA in order to get hand sanitizer back in the hands on people that need it the most during our current COVID-19 health emergency. "These guidances provide flexibility to help meet demand during this outbreak," said FDA Commissioner Stephen M. Hahn, M.D. "We will continue to work with manufacturers, compounders, state boards of pharmacy and the public to increase the supply of alcohol-based hand sanitizer available to Americans."

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FDA says coronavirus vaccine could take 1 year, despite Trump’s malaria drug claims

FDA says coronavirus vaccine could take 1 year, despite Trump’s malaria drug claims

A vaccine trial currently being performed by the FDA is expected to take "12 months" according to FDA Commissioner Stephen Hahn. This came right after President Donald Trump suggested that the drug hydroxychloroquine (HCQ) showed "very encouraging results" with COVID-19, and that "we're going to be able to make that drug available almost immediately."

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FDA will make cigarette packages more gruesome to scare smokers

FDA will make cigarette packages more gruesome to scare smokers

Although multiple efforts, including educational campaigns and higher taxes, have greatly reduced the number of smokers in only a couple of months, there are estimated to be around 34 million smokers in the United States. The FDA wants to reduce that number and plans to ramp up gruesome packaging as a disincentive. The new packaging will include imagery of lesser-known consequences linked to cigarettes.

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