Posts filtered by tags: Food and Drug Administration (FDA[x]


 

FDA aims to give full approval to Pfizer vaccine by Labor Day: report

The Food and Drug Administration (FDA) is aiming to give full approval to the Pfizer coronavirus vaccine by Labor Day, multiple people...
Tags: Fda, Food and Drug Administration FDA


Gov. Brian Kemp suggested Biden is at fault for Georgia's COVID-19 vaccination rate, which remains one of the lowest in the US

Gov. Brian Kemp of Georgia. AP Photo/John Bazemore Gov. Brian Kemp called out Biden for not working harder to push the FDA to fully approve COVID-19 vaccines. The governor pointed to the vaccine emergency authorization to explain some of the hesitation. Kemp was also critical of the CDC's new guidance on mask-wearing among vaccinated people. See more stories on Insider's business page. GOP Gov. Brian Kemp of Georgia on Thursday attempted to shift blame to President Joe Biden for th...
Tags: Politics, Cdc, US, Trends, Georgia, Joe Biden, Gop, Fda, Associated Press, Pfizer, Biden, The Washington Post, Trump, Food and Drug Administration FDA, Kemp, Centers for Disease Control CDC


If the FDA is serious about vaccine hesitancy, it should fully approve vaccines now

As the Delta inferno spreads across the country, epidemiologists worry that, although its victims are overwhelmingly the unvaccinated, continued viral replication will produce a new mutant strain that can evade natural or vaccine-induced immunity, affecting everyone. We can wind up back where we were in March 2020, with hospital ICUs overflowing and politicians re-issuing emergency orders that would place a good number of us back under house arrest. To snuff out the fire before it is too late re...
Tags: Opinion, Eu, Sport, Soccer, Delta, Fda, Pfizer, Johnson, JEFFREY, Food and Drug Administration FDA, European Medicines Agency, EUA, Kaiser Family Foundation, Phoenix AZ, Moderna, Guest Commentary


United States: Are You A Medical Device Servicer Or Remanufacturer? FDA's New Guidance May Help…Or Not - Mintz

On June 24, 2021, the Food and Drug Administration (FDA) issued the long-awaited Remanufacturing of Medical Devices Draft Guidance.
Tags: News, United States, Fda, Food and Drug Administration FDA, Mintz


United States: FDA Publishes Guidance On The Enhanced System Under The DSCSA Going Into Effect On November 27, 2023 - Winston & Strawn LLP

In June 2021, the Food and Drug Administration (FDA or the Agency) issued draft guidance (Guidance) to assist supply chain stakeholders, particularly trading partners...
Tags: News, United States, Fda, Agency, Food and Drug Administration FDA, Strawn LLP


United States: Bipartisan VALID Act Re-Introduced In Congress: Is Diagnostics Reform On The Horizon? - Mintz

In our most recent year-end blog post on devices and diagnostic products at the Food and Drug Administration (FDA), we summarized the tumultuous events of 2020...
Tags: News, Food and Drug Administration FDA, Mintz


Subway has launched a website laying out the 'truth' about its tuna

The chain has launched the website subwaytunafacts.com. Grace Dean/Insider Subway has launched the website subwaytunafacts.com to defend its tuna. The website says Subway's tuna is "high-quality, premium, and 100% real." Subway has vigorously denied claims made in a lawsuit that its tuna isn't real tuna. See more stories on Insider's business page. Subway has once again hit back at claims that its tuna isn't real tuna by launching a website called subwaytunafacts.com.Subway...
Tags: Food, News, Subway, US, Trends, Cnn, New York Times, Fast Food, Retail, Fda, Tuna, Food and Drug Administration FDA, Fred DeLuca, Grace Dean, Sandwich Shop, John Chidsey


Massachusetts school wins court battle to use electric shock therapy on self-harming disabled students

A therapist checks the ankle strap of an electrical shocking device on a student at the Judge Rotenberg Educational Center. Charles Krupa/Associated Press A Massachusetts school has won an appeal to use electric shock therapy on mentally disabled pupils. A federal court ruled that an earlier FDA ban on the therapy had been outside the agency's area of authority. The United Nations previously said the center's use of electric shock therapy amounted to "torture". See more stories on ...
Tags: Massachusetts, US, Trends, United Nations, Fda, Food and Drug Administration FDA, Canton Massachusetts, Rotenberg Educational Center, Disability Rights International, Alia Shoaib, Laurie Ahern, Massachusetts News Read


The FDA was wrong about Aduhelm

The Food and Drug Administration (FDA) negated the recommendation of its expert panel and approved Aduhelm to treat Alzheimer’s dementia (AD), contending that the possible benefit trumped the lack of evidence of efficacy. The FDA was inexcusably in error in making this decision. Aside from the likely lack of benefit, the use of this drug Read more… Find jobs at Careers by KevinMD.com. Search thousands of physician, PA, NP, and CRNA jobs now. Learn more.
Tags: Health, Fda, Neurology, Medications, Food and Drug Administration FDA, Meds, PA NP, CRNA


Immune response to FDA-approved vaccines is strong and potentially long-lasting

The first two COVID-19 vaccines authorized for emergency use by the Food and Drug Administration (FDA) employed a technology that had never before been used in FDA-approved vaccines.
Tags: Health, Fda, Food and Drug Administration FDA


Some experts who had Johnson & Johnson's single-dose vaccine are now getting extra shots of Pfizer or Moderna to try to protect against the Delta variant

A pharmacist at the Hartford Hospital in Hartford, Connecticut, fills a syringe with the Johnson & Johnson COVID-19 vaccine. Joseph Prezioso/Getty Images Some experts who got Johnson & Johnson's one-dose vaccine are topping it up with a dose of Pfizer or Moderna. They did it for extra protection against the fast-spreading Delta coronavirus variant, they said. The FDA and CDC don't recommend getting an extra shot, after a J&J vaccine or otherwise. See more stories on Insider's b...
Tags: Health, UK, Science, News, Cdc, US, Trends, Joe Biden, Healthcare, Delta, Astrazeneca, Fda, Pfizer, Vaccine, Johnson, Anthony Fauci


The FDA is broken. It's controversial approval of an ineffective new Alzheimer's drug proves the agency puts profit over public health.

The way medicinal science is funded and rubber-stamped in this country has less to do with public health than it does with profit. Skye Gould/Insider The agency's approval of a new Alzheimer's drug rightly caused an uproar. But the problems extend far beyond the drug, and far beyond the FDA: Drug science has been corrupted by the pharmaceutical industry. We must get money out of science to have safe and effective drugs. P.E. Moskowitz is an author and runs Mental Hellth, a newslet...
Tags: US, Trends, United States, New York Times, Fda, Pfizer, The New York Times, Ben Goldacre, Zoloft, New England Journal of Medicine, Food and Drug Administration FDA, Public Citizen, Biogen, US Medicare, Eli Lilly, Michael Carome


United States: FDA Publishes Guidance On The Identification And Notification Of Suspect Products As Part Of The Implementation Of The Drug Supply Chain Security Act - Winston & Strawn LLP

Earlier this month, the Food and Drug Administration (FDA or the Agency) issued guidance (Guidance) to aid trading partners (manufacturers, repackagers, wholesale distributors, and dispensers)...
Tags: News, United States, Fda, Food and Drug Administration FDA, Strawn LLP


How Pfizer and BioNTech made history with their vaccine

Wondering how Pfizer and partner BioNTech developed a COVID-19 vaccine in record time without compromising safety? Dr Bill Gruber, SVP of Pfizer Vaccine Clinical Research and Development, explains the process from start to finish."I told my team, at first we were inspired by hope and now we're inspired by reality," Dr Gruber said. "If you bring critical science together, talented team members together, government, academia, industry, public health officials—you can achieve what was previously th...
Tags: Health, Science, Technology, Innovation, Fda, Pfizer, Vaccines, Gruber, Food and Drug Administration FDA, EUA, BioNtech, Bill Gruber, Pfizer Vaccine Clinical Research and Development


The US government is blocking states from ordering Johnson & Johnson's COVID-19 vaccine so they can clear their backlog of unused doses

A clinical trial volunteer participates in Johnson & Johnson's study to test a coronavirus vaccine. Janssen The government has blocked any shipments of Johnson & Johnson's vaccine, health officials told the WSJ. States already have stockpiles of the single-dose J&J shot, and vaccination rates are falling. Millions of J&J vaccines are due to expire this month. See more stories on Insider's business page. The US government is stopping orders of Johnson & Johnson COVID-19 vaccines...
Tags: Politics, News, Cdc, White House, US, Trends, Joe Biden, Healthcare, Fda, Vaccine, Oklahoma, Johnson, Illinois, Journal, Johnson & Johnson, Food and Drug Administration FDA


Millions of Johnson & Johnson COVID-19 vaccines are set to expire this month, and states are scrambling to use up their stockpiles or send them abroad

Nurse Elizabeth Johnson administers a COVID-19 vaccine to Melissa Mendez in Reading, Pennsylvania. Ben Hasty/MediaNews Group/Reading Eagle/Getty Images States are racing to use up Johnson & Johnson vaccines set to expire later this month, per multiple reports. Ohio, which has 200,000 doses set to expire, says it can't send shots abroad or to other states. Public opinion of the jab has soured after reports of blood clots and manufacturing problems. See more stories on Insider's busi...
Tags: Science, News, Cdc, Oregon, White House, US, Trends, Pennsylvania, Arkansas, Healthcare, Ohio, Philadelphia, Michigan, Fda, Johnson, Baltimore


United States: HHS And FDA Withdraw Previous Notice, Reinstitute Unapproved Drug Initiative - Buchanan Ingersoll & Rooney PC

On May 27, 2021, the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) issued a Federal Register notice (May 27 Notice) drastically reversing course from...
Tags: News, United States, Rooney, Fda, Department of Health and Human Services HHS, HHS, Food and Drug Administration FDA


United States: FDA Publishes Guidance On Remote Interactive Evaluations For Oversight Of Drug Manufacturing And Bioresearch Monitoring Facilities During The COVID-19 Public Health Emergency - Winston & Strawn LLP

On April 14, 2021, in response to the ongoing COVID-19 public health emergency, the Food and Drug Administration ("FDA" or the "Agency") issued guidance ("Guidance") describing how it will ...
Tags: News, United States, Fda, Agency, Food and Drug Administration FDA, Strawn LLP, Public Health Emergency Winston


Moderna jab stops Covid transmission in people aged 12 to 18, trial finds

Moderna becomes second manufacturer to announce successful trial results in adolescentsCoronavirus – latest updatesSee all our coronavirus coverageMass vaccination of children against Covid-19 moved a step closer as Moderna became the second manufacturer to announce successful trial results, showing its vaccine can stop transmission in people aged 12 to 18.Pfizer/BioNTech’s vaccine has already been given emergency approval for adolescents aged 12 to 15 in the US by the regulator, the Food and Dr...
Tags: Health, US, World news, US news, Pharmaceuticals industry, Vaccines and immunisation, Pfizer, Food and Drug Administration FDA, Moderna, Coronavirus


United States: FDA Conforms Regulations To Exclude Certain Software Functions From The Definition Of Device - Winston & Strawn LLP

The Food and Drug Administration (FDA) Final Rule amending certain classification regulations to reflect changes to the Federal Food, Drug, and Cosmetic Act (FD&C Act) made by the 21st Century Cures Act (Cures Act) became effective April 19, 2021.
Tags: News, United States, Fda, Food and Drug Administration FDA, Strawn LLP


REVIEW: DiGiorno Gluten Free Pepperoni Pizza

I’ve had enough DiGiorno Pepperoni Pizzas to know that if you stuck one in a generic pizza box and told me it was delivery from some local restaurant, I’d take out the pizza, look to see if there were any grease stains on the box and if there weren’t any, I’d put it in the recycling bin. And if there were grease stains, I’d scold you for wasting a perfectly good pizza box on a poorly planned prank. My internal prank detector would also quickly notice an attempt to swap a regular DiGiorno pepper...
Tags: Reviews, Shopping, Pizza, Fda, Food and Drug Administration FDA, Digiorno, DiGiorno Pizza, Frozen Food, DiGiorno Gluten Free Pepperoni Pizza, DiGiorno Pepperoni Pizzas


The US shouldn't prioritize vaccinating teens over donating shots abroad if it wants to get back to normal, experts say

A teen 'COVID-19 student ambassador' received a dose of Pfizer at Ford Field on April 6, 2021 in Detroit, Michigan. Matthew Hatcher/Getty Images The US is expected to expand its vaccine rollout to teens as soon as Thursday. Meanwhile, low and middle income countries haven't vaccinated their most vulnerable people. To get back to normal, the US need to both immunize teens and send doses abroad, experts told Insider. See more stories on Insider's business page. In January, Dr...
Tags: Health, Politics, Abc, India, US, Los Angeles, Trends, Joe Biden, Teen, Ford, Healthcare, Who, Astrazeneca, Fda, University of Bristol, Pfizer


Colonial Pipeline restarts operations after cyber-attack forces a shutdown - as it happened

Company says it will take ‘several days’ for supply chain to normalizeThe CDC has recommended the Pfizer shot to 12- to 15-year-olds Cheney’s ousting proves the ‘big lie’ is Republican party’s religionExplainer: why did the Republican party oust her?Full story: Republicans remove Cheney over Trump criticism 12.54am BST – Joan E Greve and Maanvi Singh 12.30am BST Chemical giants DuPont and Daikin knew the dangers of a PFAS compound widely used in food packaging since 2010, but hid them fr...
Tags: Republicans, Cdc, World news, Joe Biden, US news, Democrats, US politics, House Of Representatives, DuPont, Pfizer, US Congress, Republican Party, Cheney, Trump, Food and Drug Administration FDA, Daikin


Chemical giants hid dangers of ‘forever chemicals’ in food packaging

DuPont and Daikin, manufacturers of ‘short chain’ PFAS, did not inform regulator the FDA negative results of tests on animalsChemical giants DuPont and Daikin knew the dangers of a PFAS compound widely used in food packaging since 2010, but hid them from the public and the Food and Drug Administration (FDA), company studies obtained by the Guardian reveal.The chemicals, called 6:2 FTOH, are now linked to a range of serious health issues, and Americans are still being exposed to them in greasepro...
Tags: Environment, US news, Pollution, Fda, DuPont, Food and Drug Administration FDA, Daikin


Pfizer vaccine authorised by US FDA for adolescents

The Food and Drug Administration (FDA) says it is "a significant step in the fight against the Covid-19 pandemic".
Tags: News, US, Fda, Food and Drug Administration FDA


United States: FDA Ups The Ante And Sends First Notice Of Noncompliance For Failure To Submit Clinical Trial Results - Mintz

The Food and Drug Administration (FDA) and the National Institutes of Health (NIH) have the authority to regulate clinical trial reporting requirements.
Tags: News, United States, Fda, National Institutes of Health NIH, Food and Drug Administration FDA, Mintz


Healthy Habits: Children and Herd Immunity

As the Pfizer vaccine awaits emergency authorization as soon as early next week from the Food and Drug Administration (FDA) for use in young adolescents ages 12 to 15, Miguela Caniza, MD MPH , Director of the St. Jude Global Infectious Diseases Program at St.Brought to you by: Frugal Focus
Tags: Frugality, Food and Drug Administration FDA, Miguela Caniza, St Jude Global Infectious Diseases Program


We could find out if Pfizer's COVID-19 vaccine works in kids aged 2 to 11 by September

Trial data from Pfizer's coronavirus vaccine for the youngest age-group, 6 months to 2 years, would be ready to show to the FDA later this year. Getty We could know if Pfizer's vaccine works in kids aged 2 to 11 by September, according to Albert Bourla, Pfizer CEO. Bourla said Tuesday that vaccine data for kids 6 months to 2 years was expected November-time. Exact timelines depend on how well the trials go and whether regulators approve it. See more stories on Insider's busines...
Tags: Kids, Israel, US, Trends, Joe Biden, Healthcare, Fda, Pfizer, Vaccine, Biden, US Food and Drug Administration, Food and Drug Administration FDA, Scott Gottlieb, Centers for Disease Control and Prevention Read, BioNtech, Bourla


Denmark bans Johnson & Johnson's coronavirus vaccine, citing the risk of rare blood clots

A nurse loads a syringe with a dose of Johnson & Johnson's COVID-19 vaccine on March 9, 2021 in Athens, Ohio. Stephen Zenner/SOPA Images/LightRocket via Getty Images Denmark banned Johnson & Johnson's COVID-19 vaccine on Monday. The risk of rare, unusual blood clots as a side effect outweighed the shot's benefits, authorities said. J&J's vaccine was highly effective at preventing COVID-19 in trials. See more stories on Insider's business page. Denmark has become the fir...
Tags: Cdc, France, US, Trends, Spain, Italy, Healthcare, Athens, Astrazeneca, Denmark, Fda, Vaccine, Johnson, Johnson & Johnson, J J, Food and Drug Administration FDA


Biden's menthol cigarette prohibition is so obviously stupid and wrong it boggles the mind

President Joe Biden speaks on the North Lawn of the White House on April 27, 2021 in Washington, DC. Drew Angerer/Getty Images Biden claimed to regret how his drug warrior legacy led to mass incarceration. And yet he's banning menthol cigarettes, which are popular in Black communities. But the prohibition will lead to harsher policing in those communities. It's like the president hasn't learned a thing from the failed and evil War on Drugs. This is an opinion column. The thou...
Tags: New York, Congress, Washington Post, Washington, White House, Trends, Joe Biden, Ronald Reagan, Aclu, Albert Einstein, DEA, Biden, Staten Island, Eric Garner, Einstein, Kamala Harris