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Articles tagged with "FDA"

U.S. House Passes Bill to Speed New Drugs to Market

Reuters Staff  |  

WASHINGTON (Reuters)—The U.S. House of Representatives on Friday passed a bill aimed at speeding new drugs to the market after lawmakers defeated last-minute amendments that threatened to derail it. The House voted 344 to 77 in favor of the bill, known as the 21st Century Cures Act, which would require the FDA to streamline the…

FDA Strengthens Warning Label for Certain Antiinflammatory Drugs

Reuters Staff  |  

(Reuters)—The U.S. Food and Drug Administration is strengthening an existing warning label that non-aspirin, non-steroidal antiinflammatory drugs (NSAIDs) increase the risk of heart attack or stroke. NSAIDs include ibuprofen, naproxen, diclofenac and celecoxib, all of which carry FDA warning labels. The agency said it would require updates to the labels of prescription and over-the-counter (OTC)…

White House Is Open to Working with Congress on Disease Research Bill

Reuters Staff  |  

WASHINGTON (Reuters)—The White House said on Wednesday it was open to working with Congress on a bill that would invest in disease research and would be paid for with sales of oil from U.S. emergency reserves. The House of Representatives is considering a bipartisan bill that would increase funding for the U.S. National Institutes of…

Public Rarely Knows Why FDA Rejects New Drugs

Lisa Rapaport  |  

(Reuters Health)—Drug companies generally don’t disclose all the reasons new medicines fail to win U.S. marketing approval, even though regulators often reject treatments over concerns about safety or effectiveness, a study finds. Researchers compared the details companies made public in press releases with confidential documents from the U.S. Food and Drug Administration known as complete…