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Canada: Wait, Wait…Don't Sell Me! FDA And Other Pre-Market Considerations For Commercial Products - Dickinson Wright PLLC

The Food and Drug Administration (FDA) is a consumer protection agency that ensures the safety and efficacy of certain products in the US, such as medical devices, drugs, and prescriptions, tobacco products...
Tags: News, US, Canada, Fda, Don, Food and Drug Administration FDA, Dickinson Wright


Dr. Oz is running for US Senate in Pennsylvania. Here are 8 times he's made false or baseless medical claims.

Dr. Mehmet Oz attends a press conference in Istanbul, Turkey, July 2, 2019.Onur Coban/Anadolu Agency via Getty Images Dr. Mehmet Oz, one of the US' best-known celebrity doctors, is running for US Senate in Pennsylvania.  But his health recommendations are not always supported by scientific evidence. Here are eight times Oz made false, baseless, or misleading scientific claims. Visit Business Insider's homepage for more stories. Among Dr. Mehmet Oz's achievements are ten Emmy award...
Tags: Facebook, Politics, Texas, Science, News, Washington, New York City, US, America, Trends, Getty Images, Gmo, Fox, Pennsylvania, Gop, United States


FDA advisers vote to recommend authorization of a pill to treat Covid-19

Advisers to the US Food and Drug Administration voted 13-10 Tuesday to recommend emergency use authorization of a pill made by Merck and Ridgeback Biotherapeutics to help treat Covid-19.
Tags: Merck, Cnn, Fda, US Food and Drug Administration, Ridgeback Biotherapeutics


FDA panel narrowly recommends authorization of first antiviral to treat COVID-19

The drug, molnupiravir from Merck, is intended to be used in people at risk for severe COVID-19. The FDA panel authorized its use by a vote of 13-10.       [Author: USA TODAY]
Tags: Usa, News, Merck, Fda, Usa Today


FDA advisers vote to recommend authorization of a pill to treat Covd-19

Advisers to the US Food and Drug Administration voted 13-10 Tuesday to recommend emergency use authorization of a pill made by Merck and Ridgeback Biotherapeutics to help treat Covid-19.
Tags: Merck, Cnn, Fda, US Food and Drug Administration, Ridgeback Biotherapeutics


Fourth Stimulus Check: Should You Expect Another Relief Payment?

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Tags: Florida, New York, Texas, News, Minnesota, Maryland, Pua, Congress, California, Washington, Senate, Massachusetts, Elizabeth Warren, West Virginia, Bank Of America, Joe Biden


Pfizer CEO is 'very confident' the company's oral COVID-19 pill will be effective against the new variant

Pfizer CEO Albert BourlaCrystal Cox/Insider Pfizer's CEO told CNBC his company's oral COVID-19 treatment will work against the Omicron variant. "I'm very very confident that this drug works for all known mutations, including the Omicron one," he said. Pfizer said the antiviral pill led to a 89% reduction in hospitalizations and deaths in a study. Pfizer CEO Albert Bourla said he believes his company's COVID-19 oral treatment will work in patients diagnosed with the Omicron var...
Tags: News, Trends, Merck, South Africa, Healthcare, Food And Drug Administration, Fda, Pfizer, Cnbc, Reuters Pfizer, Andrew Dunn, Albert Bourla, Bourla, Allana Akhtar, Coronavirus, COVID


Pfizer expected to seek additional FDA authorization for boosters

Pfizer is expected to seek authorization from the US Food and Drug Administration for its vaccine booster shot for those who are ages 16 and 17, a source familiar with the plan told CNN on Monday.
Tags: News, Cnn, Stories, Fda, Pfizer, US Food and Drug Administration


Pfizer expected to seek FDA authorization for boosters for those ages 16 and 17

Pfizer is expected to seek authorization from the US Food and Drug Administration for its vaccine booster shot for those who are ages 16 and 17, a source familiar with the plan told CNN on Monday.
Tags: Cnn, Fda, Pfizer, US Food and Drug Administration


Hand sanitizer recalled because packaging looks like water bottles, company says

A hand sanitizer recall, with the FDA's knowledge, was issued for product in 8-ounce bottles, which bear a striking similarity to water bottles.       [Author: Shreveport Times]
Tags: News, Fda, Shreveport Times


FDA Says Merck COVID Pill Effective, Experts Will Review Safety

U.S. health officials say Merck's experimental COVID-19 pill is effective but they raised questions about its safety during pregnancy.
Tags: News, Merck, Fda


United States: FDA Joins Other Regulators In Focus On AI And Machine Learning - Sheppard Mullin Richter & Hampton

The Food and Drug Administration recently sought comments on the role of transparency for artificial intelligence and machine learning-enabled medical devices.
Tags: News, United States, Food And Drug Administration, Fda, Hampton, Mullin Richter


'Lazy eye' in kids is an age-old problem: A new VR headset brought treatment into the 21st century

The virtual reality headset, which will be available June 2022, is FDA approved for children ages 4 to 7 for one hour a day, six days a week.       [Author: USA TODAY]
Tags: Usa, News, Fda, Usa Today


Alzheimer's nasal vaccine to enter human trials for the first time, spurring renewed hope for preventing the disease

A laboratory worker tests a nasal spray (not related to Alzheimer's) at the Pharma and Beauty factory in Saint-Chamas, France, on January 21, 2021.Nicolas Tucat/AFP/Getty Images Brigham and Women's Hospital is spearheading the first human trial of an Alzheimer's nasal vaccine. The vaccine is designed to prevent or slow the progression of the disease. It uses a drug, Protollin, to stimulate immune cells to remove sticky plaque from the brain. Alzheimer's treatments seemed like ...
Tags: Science, News, Drugs, US, Trends, Alzheimer's Disease, Food And Drug Administration, Fda, Vaccines, Eisai, Cummings, Brigham, Alzheimer, University of Nevada Las Vegas, William Burke, Biogen


Theranos founder Elizabeth Holmes admits to adding Pfizer logo to company reports and hiding the use of third-party devices: Trial week 12 recap

Brittany Hosea-Small/Reuters Theranos founder Elizabeth Holmes returned to the stand this week in her criminal fraud trial. She admitted using Pfizer's logo without authorization but said, "I wish I had done it differently." Holmes also said she concealed Theranos' use of third-party devices over trade secret concerns. Theranos founder Elizabeth Holmes continued testifying in the 12th week of her federal fraud trial this week. Her defense has argued she couldn't have knowingly dup...
Tags: News, Stanford, Africa, Trends, Merck, Walgreens, New York Times, Fda, Npr, Trial, Pfizer, Siemens, Cnbc, Theranos, Gibbons, Elizabeth Holmes


United States: Got Salt? Maybe Not As Much Following FDA's Voluntary Sodium Reduction Goals. - Michael Best & Friedrich

Sodium is widely present in the American diet. Primarily, but not exclusively, as a result of eating or drinking foods to which sodium chloride or "salt" has been added.
Tags: News, United States, Fda, Friedrich, Michael Best


United States: Medical Products Supply Chain Week In Review – FDA Authorizes Pfizer And Moderna Booster For All Adults - Alston & Bird

In the past week, the FDA authorized the Pfizer and Moderna booster shots for all adult age groups, while the CDC Advisory Committee on Immunization Practices (ACIP) also recommended the Moderna vaccine booster for all adults.
Tags: News, United States, Fda, Pfizer, Alston, Moderna


United States: Three Key Takeaways From FDLI's Panel Discussion On FDA's Digital Health Center Of Excellence And Working With The FDA In The Digital Health Space - Morrison & Foerster LLP

Three Key Takeaways From FDLI's Panel Discussion On FDA's Digital Health Center Of Excellence And Working With The FDA In The Digital Health Space
Tags: News, United States, Fda, Foerster LLP, FDLI, Digital Health Center, Digital Health Space Morrison


United States: Can Real-World Evidence Transform Healthcare? Recent FDA Activities Indicate Yes - Morrison & Foerster LLP

Health policy experts have talked excitedly about the potential for real-world evidence (RWE) to transform healthcare delivery and drug development for years.
Tags: News, United States, Fda, Morrison, RWE, Foerster LLP


United States: In House Warrior With Daniel Kracov (Podcast) - Arnold & Porter

In this podcast, Daniel Kracov joins Levick's In House Warrior to discuss clinical trials during the COVID-19 pandemic, FDA regulation and healthcare privacy."
Tags: News, United States, Fda, Porter, Levick, Daniel Kracov


The FDA will soon decide on Merck's Covid-19 antiviral pill

In the fall of 2015, Dr. Mark Denison was preparing for a long drive home from Alabama after making a presentation at a scientific meeting when a colleague asked him to stick around for lunch and check out some data on a potential new drug.
Tags: News, Alabama, Merck, Stories, Fda, Mark Denison


The FDA will soon decide on Merck's Covid-19 antiviral pill. It shows promise, but there are also concerns

In the fall of 2015, Dr. Mark Denison was preparing for a long drive home from Alabama after making a presentation at a scientific meeting when a colleague asked him to stick around for lunch and check out some data on a potential new drug.
Tags: Alabama, Merck, Cnn, Fda, Mark Denison


State Inspections Confirm Whistleblower Allegations At Troubled California COVID Lab

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Tags: News, California, Seen On, California News, Sacramento, Fda, CBS Records, PerkinElmer, California Department of Public Health, Newsom, CDPH, Scott Wilk R Santa Clarita, Newsom Administration, Investigations (section page, COVID-19, Julie Watts Investigates


United States: The Status Of COVID Vaccine Mandates In The Shadow Of FDA Action - Michelman & Robinson LLP

For many here in the U.S., the COVID-19 vaccine remains a hot button and rather divisive issue.
Tags: News, United States, Fda, Michelman, Robinson LLP


Linda Evangelista says CoolSculpting left her disfigured. Five women say it happened to them too

A doctor holds the instrument used in CoolSculpting.Anne Cusack/Los Angeles Times via Getty Images CoolSculpting has been sold as a quick and easy route to a slimmer silhouette. Supermodel Linda Evangelista filed a lawsuit in September saying CoolSculpting left her disfigured due to an adverse reaction known as PAH. Sometimes called the "stick of butter effect," PAH may be more common than people think. Insider talked to women who experienced it.  For the last decade, CoolSculpting has been m...
Tags: Facebook, Florida, New York, Science, News, Instagram, Medicine, Obesity, California, Trends, Body Image, Fat, Plastic Surgery, Khloe Kardashian, Diana, Fda


Fourth Stimulus Check: Should You Count On Another Relief Payment?

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Tags: Florida, New York, Texas, News, Minnesota, Maryland, Pua, Congress, California, Washington, Senate, Massachusetts, Elizabeth Warren, West Virginia, Bank Of America, Joe Biden


At least 25 people poisoned by toxic alkaline water, says FDA

People like Gwyneth Paltrow tout alkaline water as a health tonic. She even squeezes lemon into her alkaline water. I wasn't paying a lot of attention in middle school chemistry, but I do seem to remember that mixing a base and and and acid yields a salt. — Read the rest
Tags: Post, News, Fda, Gwyneth Paltrow, Snake Oil


COVID-19 booster shots and breakthrough infections: Your questions answered

USA TODAY spoke about boosters with Dr. Peter Marks, head of the FDA division that has been reviewing vaccines. Here's what you should know.       [Author: USA TODAY]
Tags: Usa, News, Fda, Usa Today, Peter Marks


Recall Announced For Certain Onions Due To Salmonella Outbreak

SACRAMENTO (CNN) – The US Food and Drug Administration along with the Centers for Disease Control and Prevention are advising consumers to avoid purchasing certain onions due to a Salmonella outbreak reported in 38 states and Puerto Rico, according to a CDC news release. Multiple companies have recalled whole yellow, red, and white onions due to the potential risk of Salmonella, all of which were “supplied by ProSource Produce LLC and Keeler Family Farms and imported from the State of Chihuahua,...
Tags: News, California, Cdc, Local, Sacramento, Fda, Salmonella, Centers For Disease Control And Prevention, Puerto Rico, US Food and Drug Administration, Chihuahua Mexico, Food Recall, Sacramento News, Cable News Network Inc, WarnerMedia Company, ProSource Produce LLC



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