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SCHOOL CLOSINGS

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FOOD AND DRUG ADMINISTRATION


Here’s why parents could see stocked formula shelves at Metro Detroit grocery stores

A few months ago, baby formula was tough to find, putting parents in a difficult situation.

Moderna seeks to be 1st with COVID shots for littlest kids

Moderna is asking U.S. regulators to open its COVID-19 vaccine to the nation's youngest children.

Risk vs. reward: US panel narrowly recommends Merck’s COVID pill

An anti-COVID pill made by drugmaker Merck has been under review by officials, and on Wednesday its fate rested in the hands of the FDA.

Flagship Food Group recalls frozen cauliflower due to health concern

Flagship Food Group has issued a voluntary recall of TJ Farms brand frozen cauliflower due to a potential health risk.

Conagra Brands recalls some Birds Eye Broccoli Tots over reports of small rocks, metal fragments in product

Conagra Brands, Inc. has issued a voluntary recall of some of its Birds Eye Broccoli Tots after some consumers reported finding small rocks and metal fragments in the product.

FDA advisory committee votes to approve Johnson & Johnson vaccine booster shots

The outside panel of experts voted unanimously in favor of offering booster doses of the Johnson & Johnson vaccine at least two months after the first dose.

FDA advisory committee votes to approve Moderna vaccine booster shots for vulnerable groups

The outside panel of experts voted unanimously in favor of offering Moderna boosters to specific groups of people, at least six months after their second dose.

Here’s how much the FDA is hoping to lower daily salt intake for Americans

The Food and Drug Administration is taking new steps to try to lower the amount of salt Americans take in on a daily bases.

FDA advisory panel to meet on Moderna, Johnson & Johnson COVID vaccine booster shots

The Food and Drug Administration’s vaccine advisory panel is set to meet Thursday and Friday, Oct. 14-15, and we are getting our first look at the data the panel will be using to make its recommendation on booster shots for Moderna and Johnson & Johnson.

Merck asks FDA for emergency use authorization for COVID-19 pill

Drugmaker Merck asked U.S. regulators Monday to authorize its pill for treating COVID-19 in what would add an entirely new and easy-to-use weapon to the world’s arsenal against the pandemic.

What is the hold up on COVID vaccines for kids under age 12?

It’s collision course that has parents worried -- kids heading back to school, COVID precautions being dropped and the delta variant surging.

What to look for when choosing sunscreen

Experts suggest wearing sunscreen all day long when spending time outdoors, especially in the summer -- but with so many brands and types of sunscreen to choose from, picking the right one can be overwhelming.

New Device Taps Brain Signals To Help Stroke Patients Regain Hand Function

After a stroke, people often lose dexterity in one hand. Now, the Food and Drug Administration has authorized a device that can restore function by encouraging the brain to rewire.

npr.org

FDA advisory panelist in Michigan explains voting in favor of Moderna COVID-19 vaccine

ANN ARBOR, Mich. – The U.S. Food and Drug Administration granted an emergency use authorization for the Moderna COVID-19 vaccine Friday evening, the second vaccine to be authorized in the country. Prior to the authorization, the FDA advisory panel voted 20-0 with one abstention on Thursday to recommend the vaccine. UPDATE: US clears Moderna vaccine for COVID-19, 2nd shot in arsenalDr. A Oveta Fuller, a virologist and viral pathogen researcher at the University of Michigan, voted “No” to recommend the Pfizer vaccine. However, she said she voted “Yes” this time for Moderna. It seemed like their study was set up to meet that at the minimum but it wasn’t set up to do a whole lot else,” Fuller said.

Here’s a look at FDA’s COVID-19 vaccine review process

Scientists with the U.S. Food and Drug Administration (FDA) are working to review two COVID-19 vaccines submitted by drug companies Pfizer and Moderna. Pfizer submitted its application on Nov. 20 for an emergency use authorization to the FDA Center for Biologics Evaluation and Research (CBER). “The safety profile of a vaccine that’s going to be deployed in millions of people has to be incredibly clean,” said Dr. Peter Marks, who directs CBER. “We, as an agency, are one of the last agencies in the world that we still actually get the primary data. We don’t get summary data.”CBER receives raw data on all participants in a vaccine trial, in addition to volumes of information on every aspect of the vaccine.

FDA authorizes rapid at-home COVID-19 test

When it comes to COVID testing, we’ve been hearing about growing lines and delayed results. But the Food and Drug Administration (FDA) issued a new emergency use authorization for an at-home test. The new test by California-based Lucira is a nasal swab test that can provide a result within 30 minutes and is for use by anyone ages 14 and older if their healthcare provider thinks they may have COVID-19. The nasal swab test involves swirling a patient’s self-collected sample swab in a vial, which is then placed in the test unit. The FDA did not talk about the price of the test but the company’s website indicated that the test is intended to cost less than $50.

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