FDA (KFF Health News) ++++

FDA The New York Times: F.D.A. Opens Door To More Flavored E-Cigarettes https://www.nytimes.com/2026/03/09/health/fda-e-cigarettes-flavors.html?utm_campaign=KHN%3A%20First%20Edition&utm_medium=email&_hsenc=p2ANqtz-_no3VbqpKP5dAB9mvP4dRiidGKvapAohVhC_NKuL6J5y759kLK_8gErVFZbEmW1WJKuAEJQ_3P7ypSs2YtDGezErBpXg&_hsmi=407915789&utm_content=407915789&utm_source=hs_email The Food and Drug Administration said on Monday that it would open the door to e-cigarettes in flavors that it deems appealing to adults, shifting from the agency’s unsuccessful ban on fruit and candy-flavored versions that have continued to flood the market. The agency said in a document released on Monday that it would consider vapes in flavors such as mint, coffees, teas and spices, possibly like clove or cinnamon. The F.D.A. said it would continue to reject those offering sweet or fruity flavors that are more appealing to teenagers. (Jewett, 3/9) Bloomberg: FDA Plans To Loosen Testing Rules To Boost Biosimilar Drugs https://www.bloomberg.com/news/articles/2026-03-09/fda-plans-to-loosen-testing-rules-to-boost-biosimilar-drugs?utm_campaign=KHN%3A%20First%20Edition&utm_medium=email&_hsenc=p2ANqtz--BJjCJRuTE6864jfATx1cz9jWvF_XX1eSLlsskeQdUkOyENhAyaK1Soe480hg39RoBVEXvKgI8GW02sGlCSSHAuj7UKw&_hsmi=407915789&utm_content=407915789&utm_source=hs_email&embedded-checkout=true The US Food and Drug Administration is easing some requirements for drugmakers developing copycat versions of costly biologic medications in a bid to bring more competition to the market and lower costs. The agency plans to reduce the need for some studies that demonstrate the drugs, called biosimilars, are equivalent to the brand-name medications they’re modeled on, according to an FDA official who asked not to be identified and a document reviewed by Bloomberg News. The agency estimates the change could shave $20 million from the cost of developing a new biosimilar drug. (Tozzi, 3/9) Undark: Why The FDA Is Embracing Old Math For New Drugs https://undark.org/2026/03/10/fda-bayesian-guidelines/?utm_campaign=KHN%3A%20First%20Edition&utm_medium=email&_hsenc=p2ANqtz-9m3gdRXHaF5AUjlOXPgKNevDKq23KdFRKYz7KQnYHZc3pQDLmbN71Vp2D1eJ4cVrmGhUm8qWdQVqpT2BQMUsocCihoOQ&_hsmi=407915789&utm_content=407915789&utm_source=hs_email Clinical trials for a new drug can take years to complete, and cost up to hundreds of millions of dollars. New draft guidance from the U.S. Food and Drug Administration aims to make that process faster and cheaper for some studies, by encouraging a tool called Bayesian statistics. The approach dates back more than 250 years, and proponents say its embrace by regulators is overdue, stalled at first by feuding camps of statisticians, then later by a lack of familiarity among trained professionals. (Talpos, 3/10) Bloomberg: FDA Investigated Over Rare-Disease Drug Denials By Senator https://www.bloomberg.com/news/articles/2026-03-10/key-us-senator-investigates-fda-over-rare-disease-drug-denials?utm_campaign=KHN%3A%20First%20Edition&utm_medium=email&_hsenc=p2ANqtz--D1gjigo1Bj1eq58QlgEz7DK1_CBB8TXnZbqDJIo6R-mcawRF-9VnbkT3aEZ_5ChaRaw3CN_SVY_Eest4cVMjE0VfbRQ&_hsmi=407915789&utm_content=407915789&utm_source=hs_email A key US Republican senator said he’s launched an investigation into the Food and Drug Administration’s recent denials of treatments for rare diseases, adding political pressure on an agency that’s already in turmoil. Wisconsin Sen. Ron Johnson said he’s seeking the FDA’s written denials to drugmakers, known as complete response letters. He plans to write letters to the agency asking why it denied certain drugs. He said he’s also considering having top FDA officials, including Commissioner Marty Makary, testify before the Senate’s Permanent Subcommittee on Investigations that he chairs. (Langreth, Smith, and Cohrs Zhang)