New information technology gives the U.S. an opportunity to accelerate the development, review, and approval of new medicines. This can be done through greater use of real-world data (RWD) and real-world evidence (RWE) rather than through the results of expensive clinical trials alone.

Regulations slow down the economy; Even regulations that might be considered beneficial have a drag on the economy. What’s worse, though, is allowing other countries to evade these regulations. What does it say about the rule of law? And, what does it say to entrepreneurs here at home?

A clinical trial comparing a one-page medication handout proposed by the U.S. Food and Drug Administration (FDA) with an updated version developed by researchers at the University of Pittsburgh that quantifies a drug's risk and benefits showed that the latter was more informative and helped patients feel better equipped to make decisions.

It had authorized just 1/1,000th of one percent of the applications it’s received and had a backlog of 557,000 pending applications for new products. That’s impressive inaction. Meanwhile, the U.S. market is flooded with illicit Chinese-made vapes.

Patients might think the US Food and Drug Administration’s stamp of approval means that a product is the last word on safety, but about a third of the drugs the FDA approved between 2001 and 2010 were involved in some kind of safety event after reaching the market, according to a study published Tuesday in the Journal of the American Medical Association.

Federal regulators responsible for the safety of the U.S. drug supply are still struggling to get back to where they were in 2019, before the COVID-19 pandemic upended factory inspections in the U.S. and across the world, The Associated Press has found.

Products sold in Europe, Japan and South Korea offer more protection from the sun. In the U.S., the key ingredients aren't FDA-approved.

That means many drugs that made it to market with an accelerated approval are being used – sometimes for years – without patients, doctors or regulators knowing if they really work.

The decision, lauded by consumer advocacy groups, comes a full 25 years after scientists at the agency determined that rats fed large amounts of the artificial color additive were much more likely to develop malignant thyroid tumors than rats who weren't given the food coloring.

China, Brazil, the Philippines, South Africa, and India arguably have greater access to gene therapies than the US. So why aren’t there more gene therapies available to help US patients? The answer boils down to regulation.

There have been dozens of eye drops pulled off shelves in the past year due to bacterial and fungal contamination, with multiple warnings issued by the Food and Drug Administration.

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

The US Food and Drug Administration is tasked with protecting consumers from unsafe food and medical products. In new research, Parker Rogers finds that FDA regulations can not only hinder innovation and competition but often the improvements to product safety they are supposed to encourage.

The U.S. Food and Drug Administration failed to adhere to its own guidance and internal practices during the approval process for Biogen’s Alzheimer’s drug Aduhelm, which was “rife with irregularities,” a congressional report showed on Thursday.

A new report criticizes the Food and Drug Administration’s efforts to oversee the tobacco industry, including traditional cigarettes and vaping products

The Food and Drug Administration (FDA) needs major restructuring to put a single person in charge of its food safety program, according to an outside review of the agency commissioned in the wake of the infant formula crisis.

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

Florida sued federal health officials on Wednesday, accusing them of stalling the state’s plan to import lower-cost prescription drugs from Canada.

If the FDA approves a bad drug, the adverse outcomes make headlines. If the FDA delays a good drug, the cost is less obvious because most of those affected are not aware their illness could have been treated more effectively.

Four hundred thousand doses of the monkeypox vaccine that had expired and were destined to be destroyed have been tested from American stockpiles and found to still be viable, the chief executive of vaccine manufacturer Bavarian Nordic told POLITICO.

The Brookings Institution’s report has highlighted some concerns within FDA’s current regulatory processes. Specifically, these relate to three measures to promote improved generic drug competition: the Citizen Petition mechanism; the approval of ‘complex generic drugs’; and generic drug ‘parking’.

To ease the U.S. shortage of baby formula, Nature's One and Holle are poised to ship hundreds of thousands of pounds, if not millions of pounds, of additional formula into stores, company executives told Reuters. They may be waiting a while.

Lawmakers grilled U.S. Food and Drug Administration officials on Wednesday over what they saw as a lack of urgency in the agency's response to complaints about possible baby formula contamination at a now shuttered Abbott Laboratories plant that led to severe nationwide shortages.

The head of the Food and Drug Administration said Wednesday that efforts to investigate problems at a baby formula plant linked to the nationwide shortage were slowed by COVID-19, scheduling conflicts and even a missing piece of mail.

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

The first U.S. sales of the AquAdvantage salmon, a faster- growing, genetically engineered fish, have finally begun... It is coming to market after a quarter-century and close to $100 million spent trying to get the approval of federal regulators. In addition to governmental foot-dragging, the journey was constantly dogged by activists opposed to genetically engineered food.

Spurred by decades of complaints about the high cost of hearing aids, Congress passed a law in 2017 to allow over-the-counter sales, with hopes it would boost competition and lower prices. Four years later, federal regulators have yet to issue rules to implement the law. But changes in the industry are offering consumers relief.

An argument between FDA and industry over the legality of NAC in dietary supplements essentially forces Amazon--and other retailers--to take sides.

When the FDA wants to, it can get desperately needed products expeditiously to those who need them. But for some other innovations, and even entire product classes, the FDA slows or obstructs approval, sometimes by imposing nearly insuperable regulatory burdens.

...a group of health, environmental, and consumer organizations challenged the Food and Drug Administration’s (FDA) practice of not accounting for the cumulative health effect of chemicals in the diet when allowing new chemicals in food.

A panel of government health advisers said Friday there’s no clear evidence that a harder-to-crush version of the painkiller OxyContin designed to discourage abuse actually resulted in fewer overdoses or deaths.

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

A newly released report says the Food and Drug Administration may have failed to set strict enough standards and follow-through for training doctors about the risks associated with opioids. Researchers say lack of oversight and training problems happened while the opioid crisis killed tens of thousands of people a year.

A few academics recently argued that “partisan political interposition has grown increasingly worrisome. As the sole arbiter standing between a New Drug Application and a potential public health calamity, the FDA can hardly afford to be buffeted by undue political interference,” and should, therefore, become an independent agency. A group of former heads of the agency have made a similar recommendation.

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 Food and Drug Administration (FDA) and manufacturers did not take action when evidence emerged that potentially lethal fentanyl products were being inappropriately prescribed to patients.

Businesses that founder or just never get launched won't suffer anywhere nearly as much as the people who would have benefited from their innovations.

U.S. regulators cleared the first generic competitor to Mylan’s EpiPen, after a years long delay that many said contributed to the emergency allergy drug’s rapid rise in price.

The Food and Drug Administration is under pressure from the Trump administration to approve drugs faster, but researchers at the Yale School of Medicine found that nearly a third of those approved from 2001 through 2010 had major safety issues years after they were widely available to patients.

Consumers and Congress members pushing for cheaper alternatives to the EpiPen and other high-priced drugs are seeking answers about a stubborn backlog of generic drug applications at the Food and Drug Administration that still stretches almost four years.

Consumers and lawmakers pushing for cheaper alternatives to the EpiPen, an antidote for life-threatening allergic reactions, and other high-priced drugs are seeking answers about a stubborn backlog of generic drug applications at the Food and Drug Administration.

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

New technologies are poised to launch a health care revolution, improving care and cutting costs. Unfortunately, an obsolete regulatory framework for medical devices threatens to slow or derail important components of that revolution.

Medical innovation has been suffocated by the FDA’s flawed drug approval process. An increasing number of scholarly individuals recognize that delaying lifesaving therapies can no longer be tolerated, including former FDA Commissioner Andrew von Eschenbach.

Metformin Makes Headline News

Numerous reports reveal the FDA is in far worse shape than originally thought. Few people comprehend the fatal repercussions of FDA failures that range from approving dangerous drugs by disseminating fraudulent safety data to stifling medical innovation via bureaucratic incompetence. Find out what Life Extension is doing to persuade Congress to radically reform this troubled federal agency.

Since 1984, The Life Extension Foundation has battled against the high-cost of prescription drugs. We long ago predicted that a health care cost crisis would erupt if Congress did not reign in the artificially inflated prices that Americans pay for their prescription medications.

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

Yes, the FDA recently approved ribavirin for the treatment of hepatitis C, but with a catch. How a senseless restriction hurts people.