News from u.s. food and drug administration A wide array of domestic and global news stories; news topics include politics/government, business, technology, religion, sports/entertainment, science/nature, and health/lifestyle.

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Nov 15, 2019, 17:29 ET FDA approves first contact lens indicated to slow the progression of nearsightedness in children

The U.S. Food and Drug Administration today approved the first contact lens indicated to slow the progression of myopia (nearsightedness) in children ...


Nov 15, 2019, 17:17 ET FDA In Brief: FDA recommends discarding or destroying yellowfin/ahi tuna imported from Truong Phu Xanh Co., LTD with production dates in 2019

"Based on our traceback investigation of recent cases of Scombrotoxin fish poisoning, the FDA is warning all sectors of the supply chain to discard...


Nov 15, 2019, 16:53 ET La FDA emite una carta de advertencia a las tiendas Dollar Tree por recibir medicamentos potencialmente nocivos

In English - La Administración de Alimentos y Medicamentos de los Estados Unidos (FDA por sus siglas en inglés) ha emitido una carta de advertencia a ...


Nov 15, 2019, 15:17 ET FDA approves first targeted therapy to treat patients with painful complication of sickle cell disease

Today, the U.S. Food and Drug Administration approved Adakveo (crizanlizumab-tmca), a treatment to reduce the frequency of vaso-occlusive crisis – a...


Nov 15, 2019, 14:01 ET FDA clears first duodenoscope with disposable elevator piece, reducing the number of parts needing disinfection

The U.S. Food and Drug Administration today cleared for marketing in the U.S. the first duodenoscope with a sterile, disposable elevator component...


Nov 14, 2019, 18:13 ET FDA approves new antibacterial drug to treat complicated urinary tract infections as part of ongoing efforts to address antimicrobial resistance

The U.S. Food and Drug Administration today approved Fetroja (cefiderocol), an antibacterial drug for treatment of patients 18 years of age or older...


Nov 14, 2019, 15:45 ET FDA approves therapy to treat patients with relapsed and refractory mantle cell lymphoma supported by clinical trial results showing high response rate of tumor shrinkage

Today, the U.S. Food and Drug Administration granted accelerated approval to Brukinsa (zanubrutinib) capsules for the treatment of adult patients...


Nov 14, 2019, 12:20 ET FDA issues warning letter to Dollar Tree stores for receiving potentially unsafe drugs

The U.S. Food and Drug Administration has issued a warning letter to Greenbrier International, Inc., doing business as Dollar Tree, for receiving...


Nov 08, 2019, 12:27 ET FDA approves first therapy to treat patients with rare blood disorder

Today the U.S. Food and Drug Administration granted approval to Reblozyl (luspatercept–aamt) for the treatment of anemia (lack of red blood cells) in ...


Nov 06, 2019, 15:55 ET Statement from Center for Drug Evaluation and Research Director Janet Woodcock. M.D., on the agency's efforts to protect patients through postmarket drug safety surveillance practices

Public health and safety is the highest priority at the U.S. Food and Drug Administration. We maintain a robust practice of postmarket surveillance...


Nov 05, 2019, 13:57 ET FDA authorizes marketing of first next-generation sequencing test for detecting HIV-1 drug resistance mutations

Today, the U.S. Food and Drug Administration authorized marketing of a test to detect human immunodeficiency virus (HIV) Type-1 drug resistance...


Nov 01, 2019, 15:25 ET Statement from Janet Woodcock, M.D., director of FDA's Center for Drug Evaluation and Research on new testing results, including low levels of impurities in ranitidine drugs

Americans deserve to have confidence in the quality of drugs the U.S. Food and Drug Administration regulates – from the prescription medicines they...


Oct 30, 2019, 15:33 ET USDA, EPA and FDA announce partnership with the Food Waste Reduction Alliance

Today, the U.S. Department of Agriculture (USDA), the U.S. Environmental Protection Agency (EPA), and the U.S. Food and Drug Administration (FDA)...


Oct 29, 2019, 16:41 ET Digital submission of adverse event reports for investigational new drug applications reflects FDA's ongoing modernization efforts

The U.S. Food and Drug Administration is taking steps towards requiring electronic submission of certain safety reports for products being evaluated...


Oct 29, 2019, 11:05 ET Statement from Acting FDA Commissioner Ned Sharpless, M.D., and Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research, on FDA's new report regarding root causes and potential solutions to drug shortages

One of the U.S. Food and Drug Administration's top priorities is to ensure that Americans have access to safe and effective medicines. Sometimes, for ...


Oct 25, 2019, 12:50 ET Statement from Acting FDA Commissioner Ned Sharpless, M.D., on concerns with medical device availability due to certain sterilization facility closures

As the agency responsible for ensuring the safety and effectiveness of all medical devices, the U.S. Food and Drug Administration has been closely...


Oct 24, 2019, 11:12 ET Statement from Acting FDA Commissioner Ned Sharpless, M.D., on agency's first year accomplishments implementing SUPPORT Act authorities to address the opioids crisis

Addressing the opioid crisis continues to be one of the FDA's top public health priorities. While it is encouraging to see that, according to...


Oct 24, 2019, 10:04 ET Statement from Acting FDA Commissioner Ned Sharpless, M.D., and Center for Drug Evaluation and Research Director Janet Woodcock, M.D., on the agency's efforts to protect patients from potentially harmful drugs sold as homeopathic products

The U.S. Food and Drug Administration (FDA) recognizes that consumers may use various types of unapproved drugs, such as homeopathic drug products,...


Oct 23, 2019, 12:00 ET 食用鱼类:全国海鲜月须知事项

10月是全国海鲜月(National Seafood Month),美国食品药品监督管理局(FDA)正在推出资源,帮助孕妇、母乳喂养期妇女及幼儿家长食用更多的鱼,并做出汞含量较低的选择。 图片 - https://mma.prnewswire.com/media/1011451/Fish.jpg...


Oct 23, 2019, 12:00 ET 食用魚類:全國海鮮月須知事項

10月是全國海鮮月(National Seafood Month),美國食品藥品監督管理局(FDA)正在推出資源,幫助孕婦、母乳餵養期婦女及幼兒家長食用更多的魚,並做出汞含量較低的選擇。 FDA已圖片 -...


Oct 22, 2019, 10:44 ET FDA grants first-ever modified risk orders to eight smokeless tobacco products

The U.S. Food and Drug Administration announced today that, for the first time, it has authorized the marketing of products through the modified risk ...


Oct 22, 2019, 10:27 ET FDA, FTC warn company marketing unapproved cannabidiol products with unsubstantiated claims to treat teething and ear pain in infants, autism, ADHD, Parkinson's and Alzheimer's disease

Today, the U.S. Food and Drug Administration and the Federal Trade Commission posted a joint warning letter to Rooted Apothecary LLC, of Naples,...


Oct 21, 2019, 14:50 ET FDA approves new breakthrough therapy for cystic fibrosis

The U.S. Food and Drug Administration today approved Trikafta (elexacaftor/ivacaftor/tezacaftor), the first triple combination therapy available to...