The data on chemical food additive risks is overwhelming, but public policy does not keep up.

FDA will not allow experts who are employed by regulated industry to serve on advisory committees, t...

This study underscores that the FDA’s regulations meant to save lives at least sometimes have the op...

A report authored by over 100 oncologists noted that of the twelve new cancer drugs approved in 2012...

New information technology gives the U.S. an opportunity to accelerate the development, review, and...

The FDA’s restraints on food ingredients are limited and relatively feeble, especially compared with...

Research shows that financial relationships with drug companies impacts decision-making in ways that...

She left the agency in January, She's already CMO of Pfizer

Regulations slow down the economy; Even regulations that might be considered beneficial have a drag...

The focus should be on patients, not killing bugs in test tubes.

Fentanyl is now responsible for the most overdose deaths in the US

A clinical trial comparing a one-page medication handout proposed by the U.S. Food and Drug Administ...

It had authorized just 1/1,000th of one percent of the applications it’s received and had a backlog...

The unusual way the U.S. regulates ingredients is in the news and the hot seat right now, thanks to...

The crisis is long over, but if you were a young family with babies three years ago, scary memories...

A proposed ban on formaldehyde in chemical hair straightening products—linked to cancer and other he...

FDA ordered to disclose COVID-19 vaccine data after lawsuit, revealing transparency concerns.

Patients might think the US Food and Drug Administration’s stamp of approval means that a product is...

The U.S. food supply is generally considered safe, but tens of millions of people get sick from food...

Drugmakers plan to raise U.S. prices on at least 250 branded medications including Pfizer PFE.N COVI...

The group is also taking a $265 million provision to cover any extra settlement costs linked to the...

California-based Raw Farm CEO Mark McAfee says the recall is a “political decision” driven by East C...

Generic forms of common drugs such as Lipitor and Viagra are some of the many drugs whose safety is...

Always steps behind the rest of the world

Federal regulators responsible for the safety of the U.S. drug supply are still struggling to get ba...

Internal emails show that the US Food and Drug Administration informs employees leaving for industry...

Deaths from synthetic opioids such as fentanyl have soared in recent decades

British Medical Journal Investigates Legal Corruption by FDA

Products sold in Europe, Japan and South Korea offer more protection from the sun. In the U.S., the...

On May 6, the FDA announced a new rule to regulate medical devices.

When the Food and Drug Administration recently convened a committee of advisers to assess a cardiac...

The US Food and Drug Administration has settled a lawsuit over some of its posts about ivermectin, i...

Is the FDA secretly funding non-profits to lobby? When the agency would not honor a FOIA request las...

That means many drugs that made it to market with an accelerated approval are being used – sometimes...

New regulations may hinder access to testing for rare diseases and the ability to respond to pandemi...

“I’m concerned that the FDA is failing in its mission. It is not adequately executing its foreign in...

"There needs to be a fix for the drug preclusion clause that works against wider, low-cost access to...

FDA's failure to address device risks leads to patient harm, with thousands of complaints ignored.

The decision, lauded by consumer advocacy groups, comes a full 25 years after scientists at the agen...

Newly proposed FDA rule is ill-advised and likely exceeds statutory authority.

China, Brazil, the Philippines, South Africa, and India arguably have greater access to gene therapi...

There have been dozens of eye drops pulled off shelves in the past year due to bacterial and fungal...

While laboratories adhere to many federal and state regulations, LDTs receive significantly less ove...

We called it the invisible graveyard, the place they buried people killed by FDA delay.

House Committee on Oversight and Accountability Chairman James Comer (R-Ky.) and Subcommittee on Hea...

US pharmaceutical giant Johnson & Johnson (J&J) is to be investigated by South Africa's Competition...

In a letter shared with STAT, Sens. Ed Markey (D-Mass.) and Joe Manchin (D-W.Va.) warned FDA Commiss...

A study showed promise in treating a rare disease. The agency wouldn’t even look at the results.

FDA Says Walnuts Are Illegal Drugs

The media has caught up to the potential health benefits of metformin, something our long-term suppo...

CoQ10 was introduced in 1983, public demand for this nutrient soared. The FDA’s response was to seek...

Volumes of studies prove that fish oil can safely lower dangerous levels of triglycerides. Despite t...

“It’s no exaggeration to say that she presided over the worst medical regulatory failure in U.S. his...

As pharma companies underwrite three-fourths of the FDA’s budget for scientific reviews, the agency...

Here’s why drug prices are so high.

... the FDA seized documents from vaping producers, issued hundreds of fines, and removed flavored e...

To fully grasp drugmakers’ vehement pushback on any attempts to reduce drug prices, it’s important t...

The US Food and Drug Administration is tasked with protecting consumers from unsafe food and medical...

What Americans don’t want is to be told they can’t handle the truth. Yet when it came to at-home tes...

The U.S. Food and Drug Administration failed to adhere to its own guidance and internal practices du...

A new report criticizes the Food and Drug Administration’s efforts to oversee the tobacco industry,...

The Food and Drug Administration (FDA) needs major restructuring to put a single person in charge of...

Results FDA uses for approval can easily be faulty or fraudelent.

The U.S. Food and Drug Administration on Friday extended for the second time its review of Amicus Th...

Ultimately, determining what is healthy or unhealthy is complex. Complex problems rarely have entire...

Despite a requirement to address scientific issues within 60 days, the FDA has done nothing.

Florida sued federal health officials on Wednesday, accusing them of stalling the state’s plan to im...

If the FDA approves a bad drug it make headlines. If the FDA delays a good drug, the cost is less ob...

Four hundred thousand doses of the monkeypox vaccine that had expired and were destined to be destro...

A new reform gives people more access to potentially lifesaving treatments.

The departure of the head of the Food and Drug Administration’s tobacco science office for a job in...

The Brookings Institution’s report has highlighted some concerns within FDA’s current regulatory pro...

Agency rules, tariffs and government programs contribute significantly to U.S. supply chain problems...

Amid a decades-long concern about widespread U.S. antibiotic overuse in livestock, the FDA continues...

To ease the U.S. shortage of baby formula, Nature's One and Holle are poised to ship hundreds of tho...

Lawmakers grilled U.S. Food and Drug Administration officials on Wednesday over what they saw as a l...

The head of the Food and Drug Administration said Wednesday that efforts to investigate problems at...

At a congressional hearing, McKinsey executives testified that working for both the FDA and the manu...

Among experts on food safety, the consensus is that the FDA's food division isn't functional.

... the heart of science is unexpected discovery. Science is a wild exploration of the unknown, and...

The U.S. Food and Drug Administration (FDA) is requesting more than a half-century to review and rel...

The first U.S. sales of the AquAdvantage salmon, a faster- growing, genetically engineered fish, hav...

These days, all sorts of medications seem to come in cheaper off-brand versions made of the exact sa...

Our healthcare system is broken, a fact nobody would have disputed in precovid days. Regulatory capt...

Spurred by decades of complaints about the high cost of hearing aids, Congress passed a law in 2017...

It’s well known that stories of people who suffer while waiting for drugs to be approved rarely get...

An argument between FDA and industry over the legality of NAC in dietary supplements essentially for...

The startling price hike was precipitated by a well-intentioned federal government program, called t...

When the FDA wants to, it can get desperately needed products expeditiously to those who need them...

Innova has not yet secured Food and Drug Administration authorization to sell the tests in the Unite...

FDA was required to release a proposed rule in August under the terms of a 2017 law but missed the d...

...a group of health, environmental, and consumer organizations challenged the Food and Drug Adminis...

A panel of government health advisers said Friday there’s no clear evidence that a harder-to-crush v...