I saw the sign…and the answer is no—FDA-approved labeling apparently is not enough under state failure-to-warn laws, according to certain courts. While it has been long established that FDA-approved or mandated labeling preempts state failure-to-warn claims, some courts have decided that so...
That’s where the U.S. Food and Drug Administration — or FDA — comes in. The government regulatory agency within the U.S. Department of Health and Human Services controls the drug-approval process and is tasked with reviewing new drugs and medical devices before companies can sell them. C...
Food and Drug Administration (FDA) warnings on the labels.doi:10.1038/458137cNoneNature
The U.S. Food and Drug Administration’s original purpose was to regulate the selling of misbranded food and drugs. Over the years, the agency’s role grew to include the approval and regulation of medical devices in addition to pharmaceuticals. It also supervises drug, device and vaccine re...
The U.S. Food and Drug Administration authorized convalescent plasma therapy for patients with coronavirus disease 2019 and it permitted to be used during the pandemic because there is no approved treatment for COVID-19. The donated blood is processed to remove cells, leaving behind liquid and an...
December 27, 2011 — The US Food and Drug Administration (FDA) today issued draft guidelines that would permit drug and device makers to provide information on off-label uses, but only if the request for information is unsolicited. An unsolicited request is one not initiated in any form by ...
The US Food and Drug Administration (FDA) has asked the maker of sodium polystyrene sulfonate (Kayexalate), Concordia Pharmaceuticals, to conduct studies of the drug's potential to interact with other oral medications, which could affect efficacy. ...
"Reassessing the safety of chemicals in food as new, relevant data become available is a priority for the FDA," the spokesperson said. Pulling previously approved chemicals off the market is an uphill battle through the cumbersome federal"rulemaking"process, which requires the agency to defend its...
AstraZeneca has been successful at rolling out its long-acting complement C5 inhibitor Ultomiris in the uses approved for its predecessor Soliris – until now, that is. The drugmaker confirmed this morning that the FDA had baulked at extending the label for Ultomiris (ravulizumab) to include...
The Food and Drug Administration approved a request by Eli Lilly on Wednesday to begin marketing its tirzepatide medication, which is branded as Mounjaro for diabetes, under a new brand for weight loss as well. While Mounjaro had already been used by some patients "off-label" for weight lo...