Incompetence Reporting

New fast-track voucher program hits roadblocks, affecting Eli Lilly and Sanofi’s medicines among oth...

The agency is back to its old rote review of experimental drugs for rare diseases.

Therapies for rare and deadly disease are dying in Marty Makary’s shop.

An agency-wide LLM called Elsa was released weeks ahead of schedule.

The Food and Drug Administration is holding a drug in the balance that one family says improves the...

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

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...

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.

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...

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

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

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

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

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

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

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...

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

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

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.

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...

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...

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...

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

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...

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

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

FDA oversight of clinical trials is lax, slow moving, and secretive—and that enforcement is declinin...

...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...

FDA's regulatory failures in opioid approval and marketing fueled the opioid crisis.

FDA regulations block usage of a feature in Apple Watches that would help millions of users monitor...

A newly released report says the Food and Drug Administration may have failed to set strict enough s...

A few academics recently argued that “partisan political interposition has grown increasingly worris...

Since news of the scandal broke, the FDA says it will shut down the reporting system.

A study led by researchers at the Johns Hopkins Bloomberg School of Public Health suggests that the...

Businesses that founder or just never get launched won't suffer anywhere nearly as much as the peopl...

U.S. regulators cleared the first generic competitor to Mylan’s EpiPen, after a years long delay tha...

Drug safety issues tend to arise AFTER FDA approval

The Food and Drug Administration is under pressure from the Trump administration to approve drugs fa...

Consumers and Congress members pushing for cheaper alternatives to the EpiPen and other high-priced...

Consumers and lawmakers pushing for cheaper alternatives to the EpiPen, an antidote for life-threate...

Our prescription drugs are the third leading cause of death after heart disease and cancer.

It costs well over a billion dollars to get the average new drug approved and much of that cost come...

Montazerhodjat and Lo find that the FDA is far too conservative especially for severe diseases. FDA...

Medical innovation has been suffocated by the FDA’s flawed drug approval process. An increasing numb...

Numerous reports reveal the FDA is in far worse shape than originally thought. Few people comprehend...

Since 1984, The Life Extension Foundation has battled against the high-cost of prescription drugs. W...

Special Report: A telling tale of three people that illustrates the irony of this country’s drug pri...

Yes, the FDA recently approved ribavirin for the treatment of hepatitis C, but with a catch. How a s...