FDA

Forty years after the Hatch-Waxman Act, which provided widespread access to affordable generic versions of medications, the market is struggling with persistent shortages brought about partly by low prices.

U.S. health inspectors are still struggling to address a massive backlog of pharmaceutical plants that went uninspected during disruptions caused by COVID-19. That’s according to an analysis of government data by the Associated Press. The data shows roughly 2,000 drug manufacturing sites around the world have not had a Food and Drug Administration inspection for quality since before the pandemic....

Youth vaping levels fell to the lowest in a decade this year, according to a new report from the Centers for Disease Control and Prevention and the Food and Drug Administration.

Federal health officials have declined to approve the psychedelic drug MDMA as a therapy for PTSD. Drugmaker Lykos Therapeutics announced the FDA’s decision on Friday.

U.S. health officials have approved the first nasal spray to treat severe allergic reactions, offering an alternative to injectable products like EpiPen.

A loophole means manufacturers don’t need approval before adding new ingredients, such as natural sweeteners and texture enhancers, to foods, researchers say in an editorial.

The Food and Drug Administration’s proposal to ban formaldehyde in hair care products has been pushed back once again, and the timeline for its release remains undetermined. 

Friday’s action is the government’s strongest indication yet that switching to flavored vaping can reduce the harms traditional tobacco smoking.

Juul’s nicotine products have been allowed to stay in stores pending review of its application to sell them.

A first-of-a-kind proposal to begin using the mind-altering drug MDMA as a treatment for PTSD was roundly criticized Tuesday — a potentially major setback to psychedelic advocates who hope to win a landmark federal approval and bring the banned drugs into the medical mainstream.

Federal health regulators are set to review the first request to approve the mind-altering club drug MDMA as a treatment for PTSD. The Food and Drug Administration posted its review of the drug on Friday, raising questions about its effectiveness and potential risks, including heart problems.

The U.S. Food and Drug Administration recently said it’s OK for producers of yogurt to make that claim even though it’s based on limited evidence.

A bird flu outbreak in U.S. dairy cows has spread to more than two dozen herds in eight states. That comes weeks after the nation’s largest egg producer found the virus in its chickens. Health officials continue to stress that the risk to the public is low and that the U.S. food supply remains safe and stable.

Researchers have found that most cancer drugs granted accelerated approval by the U.S. Food and Drug Administration do not deliver on their early promise.

The first ever FDA-approved over-the-counter birth control pill is about to go on sale at pharmacies across the country. Delaware lawmakers are working to make sure insurance companies will cover the costs. NBC10’s Tim Furlong has more.

The Food and Drug Administration issued a safety warning Wednesday, saying it identified additional cinnamon products in the United States that are contaminated with lead.

The U.S. Food and Drug Administration says it has seized “thousands of units” of counterfeit Ozempic, the diabetes drug widely used for weight loss.

The lead contamination in recalled cinnamon applesauce pouches that potentially poisoned at least 65 children may have been intentional, the Food and Drug Administration said on Friday.

Repeated recalls of eyedrops are drawing new attention to the limited powers U.S. regulators have to oversee medical products made overseas. Unlike prescription drugs, eyedrops and other over-the-counter products don’t get preliminary review by the Food and Drug Administration. In the case of two eyedrop recalls earlier this year, FDA inspectors had never previously visited the plants in India. In...

U.S. regulators have approved two gene therapies for sickle cell disease.