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The Latest Breaking News from the Food and Drug Administration

FDA Aims To Stifle Medical Innovation Again

After botching COVID test approvals, the Food and Drug Administration wants power over thousands of other tests.

Reason

Slippery slope of abortion drug lawsuit

Vaccines, gender-affirming care and birth control could be next if SCOTUS rules to restrict nationwide access

Salon

US Supreme Court hears arguments in abortion pill case

U.S. Supreme Court justices on Tuesday did not appear ready to limit access to the abortion pill mifepristone, in a case that could have far-reaching implications for millions of American women and for scores of drugs regulated by the Food and Drug Administration.

France 24

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Alzheimer’s ‘breakthrough’ stalls: why a much-hyped drug is facing approval delays

The benefits of drugs such as donanemab, aducanumab and lecanemab are proving harder to quantify than potential harms, experts say

The Guardian - AU

Family Dollar is fined over $40 million due to a rodent infestation in its warehouse

The Food and Drug Administration found dead and live rodents, and their feces and urine. More than 1,200 rodents were exterminated after fumigation at the warehouse, which serves more than 400 stores.

WEKU

Beware smartwatches that claim to monitor blood sugar without skin prick, FDA says

The Food and Drug Administration has warned consumers against using "smart" devices that are marketed to measure blood sugar without piercing the skin.

LiveScience

The CDC investigates a multistate E. coli outbreak linked to raw cheddar cheese

Health officials reported 10 cases of E. coli infection, adding that the number of people sick is likely "much higher." Those cases were from California, Colorado, Texas and Utah.

WEKU

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Coronavirus FAQ: I'm immunocompromised. Will pills, gargles and sprays fend off COVID?

People who are immunocompromised continue to worry about COVID. A raft of products promise protection. Is there any evidence they can protect from infection or lessen severity of disease?

WEKU

Robitussin cough syrups recalled in the US due to microbial contamination

UK-based company Haleon recalls eight batches of cough syrup over risk to immunocompromised individuals

The Guardian - US

SCOTUS hears oral argument in challenge to Chevron deference

The Checks and Balances Letter delivers news and information from Ballotpedia’s Administrative State Project, including pivotal actions at the federal and state levels related to the separation of powers, due process, and the rule of law.

Ballotpedia

FDA allows imports of French syphilis drug alternate during US penicillin shortage

While as little as one injection of penicillin G benzathine can cure syphilis, the shortage prompted U.S. health officials to recommend giving some patients another antibiotic that requires of weeks of twice-daily pills.

Fortune

Magistrate Judge/Zoologist Recommends Dismissal of Drug Company's Libel Claim Against Scientists

An excerpt from a long report and recommendation released Wednesday by Magistrate Judge Ona Wang (S.D.N.Y.) in Cassava Sciences, Inc. v. Bredt; for more details, read the whole opinion: At various dates in 2021, the Neuroscientist Defendants filed a Citizen Petition and sent publicly available letters to the Food and…

Reason

FDA approves Florida's plan to import cheaper drugs from Canada

The Food and Drug Administration's authorization of Florida's plan to import prescription medicines from Canada is a first. But the state still has hurdles to clear before imports could begin.

WEKU

A Doctor And Mother's Plea To FDA To Help Save Children With Rare Disease

Despite what appears to be a major medical breakthrough on treatments for Sanfilippo, the Food and Drug Administration has refused to funnel the medicine through a faster approval process.

International Business Times

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WEKU

Sickle cell patient's journey leads to landmark approval of gene-editing treatment

In early December, the Food and Drug Administration approved a gene-editing treatment for sickle cell disease, the first for any illness. One patient helped pave the way.

The Independent UK

FDA finds 'extremely high' lead levels in cinnamon at Ecuador plant that made tainted fruit pouches

U.S. food inspectors found “extremely high” lead levels in cinnamon at a plant in Ecuador that made applesauce pouches tainted with the metal

WEKU

The FDA is investigating whether lead in applesauce pouches was deliberately added

The Food and Drug Administration is working with Ecuadorian authorities to investigate Negasmart, who has been supplying cinnamon to the three recalled applesauce brands.

The Conversation

When authoritative sources hold onto bad data: A legal scholar explains the need for government databases to retract information

In 2004, Hwang Woo-suk was celebrated for his breakthrough discovery creating cloned human embryos, and his work was published in the prestigious journal Science. But the discovery was too good to be true; Dr. Hwang had fabricated the data. Science publicly retracted the article and assembled a team to investigate…

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WEKU

Supreme Court to hear abortion pill case

The court's action sets up a collision between the Food and Drug Administration's 23-year study and supervision of mifepristone, and the circumstances under which it can be prescribed.

WEKU

FDA approves first gene-editing treatment for human illness

The Food and Drug Administration approved two genetic treatments for sickle cell disease, including one that uses gene-editing. The approvals offer hope for patients and signal a new medical era.

Salon

Why are we still eating Red Dye No. 3?

The synthetic dye is present in hundreds of candies, as well as snacks like Ding Dongs and Peeps

The Independent UK

FDA wants to regulate thousands of lab tests that have long skirted oversight

The Food and Drug Administration says it plans to begin regulating laboratory-based medical tests

The Independent UK

FDA skeptical of experimental ALS treatment pushed by patient advocates

The Food and Drug Administration meets this week to consider a much-debated treatment for Lou Gehrig’s disease

The Independent UK

Joe Biden sends message to Americans on Covid booster shots: ‘Stay up-to-date on vaccines’

US president’s message comes after CDC and FDA decide to recommend Covid booster shots amid rising cases

Dynamite News

US health agency recommends updated COVID boosters, President Biden calls it "important" milestone

he US health agency Centers for Disease Control and Prevention (CDC) on Tuesday authorized, approved, and recommended everyone 6 months and older get an updated COVID-19 booster.

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