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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. Articles that appear in this section may be written in English or other languages.

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14:46 ET Statement from Stephen Ostroff M.D., Deputy Commissioner for Foods and Veterinary Medicine, on National Toxicology Program draft report on Bisphenol A

One of the U.S. Food and Drug Administration's highest priorities is our role in ensuring the safety of the foods that Americans consume. We base...


Feb 21, 2018, 11:43 ET FDA oversees destruction and recall of kratom products; and reiterates its concerns on risks associated with this opioid

The U.S. Food and Drug Administration today announced the voluntary destruction and recall of a large volume of kratom-containing dietary...


Feb 16, 2018, 16:58 ET FDA expands approval of Imfinzi to reduce the risk of non-small cell lung cancer progressing

The U.S. Food and Drug Administration today approved Imfinzi (durvalumab) for the treatment of patients with stage III non-small cell lung cancer...


Feb 15, 2018, 16:29 ET Statement from FDA Commissioner Scott Gottlieb, M.D. on the efficacy of the 2017-2018 influenza vaccine

Seasonal flu has been widespread this year, impacting millions of people across the country. It has been an especially challenging season, with...


Feb 15, 2018, 12:11 ET FDA expands treatment window for use of clot retrieval devices in certain stroke patients

The U.S. Food and Drug Administration today cleared the use of the Trevo clot retrieval device to treat certain stroke patients up to 24 hours...


Feb 15, 2018, 09:54 ET Statement from FDA Commissioner Scott Gottlieb, M.D. on advancing the development of novel treatments for neurological conditions; part of broader effort on modernizing FDA's new drug review programs

New medical breakthroughs are altering how diseases are treated in ways that seemed unimaginable just a decade ago. Perhaps one of the most...


Feb 14, 2018, 13:52 ET FDA approves new treatment for a certain type of prostate cancer using novel clinical trial endpoint

The U.S. Food and Drug Administration today approved Erleada (apalutamide) for the treatment of patients with prostate cancer that has not spread...


Feb 14, 2018, 13:20 ET FDA authorizes marketing of first blood test to aid in the evaluation of concussion in adults

The U.S. Food and Drug Administration today permitted marketing of the first blood test to evaluate mild traumatic brain injury (mTBI),...


Feb 13, 2018, 15:48 ET FDA permits marketing of clinical decision support software for alerting providers of a potential stroke in patients

Today, the U.S. Food and Drug Administration permitted marketing of the Viz.AI Contact application, a type of clinical decision support software...


Feb 13, 2018, 15:30 ET Statement from FDA Commissioner Scott Gottlieb, M.D., on Administration's request for new FDA funding to promote innovation and broaden patient access through competition

New scientific opportunities, as well as advances in manufacturing and commerce, give the U.S. Food and Drug Administration new ways to advance our...


Feb 08, 2018, 11:42 ET Statement from FDA Commissioner Scott Gottlieb, M.D., on groundbreaking approval and interagency approach to bring stable supply of critical medical imaging isotope to the U.S.

Today, I'm proud to acknowledge the role the FDA played in the groundbreaking effort to develop a new imaging technology – the RadioGenix System....


Feb 08, 2018, 11:20 ET FDA and NRC pave way for the first domestic supply of the most commonly used medical isotope in diagnostic imaging

The U.S. Food and Drug Administration and the Nuclear Regulatory Commission (NRC) today took steps to ensure a stable and secure supply of a...


Feb 06, 2018, 13:49 ET Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency's scientific evidence on the presence of opioid compounds in kratom, underscoring its potential for abuse

Over the past several months, there have been many questions raised about the botanical substance known as kratom. Our concerns related to this...


Feb 02, 2018, 13:39 ET Statement from Jeffrey Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health on the recent National Toxicology Program draft report on radiofrequency energy exposure

One part of the Food and Drug Administration's mission is to ensure the safety of electronic products that emit radiation, like televisions and...


Feb 01, 2018, 15:41 ET Statement from FDA Commissioner Scott Gottlieb, M.D., on ongoing efforts to mitigate impact of saline shortages during this flu season

As flu activity remains widespread across the U.S., the FDA continues to monitor this situation closely and in coordination with our colleagues at...


Feb 01, 2018, 10:00 ET Su plan de acción para consumir alimentos seguros el día del juego

El domingo del Super Bowl® es una tradición estadounidense y una excelente manera de disfrutar la partida triple de fútbol americano, amigos y...


Feb 01, 2018, 10:00 ET Your Game Plan for a Food-Safe Game Day

Super Bowl® Sunday is an American tradition and a great way to bring together the three Fs: football, friends, and food. Most Super Bowl® party...


Jan 30, 2018, 10:26 ET Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to help prevent new addiction, curb abuse and overdose related to opioid products

The issue of opioid misuse and abuse remains one of my highest priorities and we believe it's going to take carefully developed, sustained, and...


Jan 30, 2018, 09:55 ET FDA, USDA announce formal agreement to bolster coordination and collaboration

U.S. Agriculture Secretary Sonny Perdue and FDA Commissioner Scott Gottlieb, M.D. announced at the White House today a formal agreement aimed at...


Jan 26, 2018, 11:33 ET FDA approves new treatment for certain digestive tract cancers

The U.S. Food and Drug Administration today approved Lutathera (lutetium Lu 177 dotatate) for the treatment of a type of cancer that affects the...


Jan 26, 2018, 10:37 ET Statement from FDA Commissioner Scott Gottlieb, M.D. on FDA's strengthened commitments to humane and judicious animal research and the termination of a nicotine study

The FDA has a deep commitment to ensuring the responsible and humane care of animals when research involving animals is needed to fulfill the...


Jan 24, 2018, 09:53 ET FDA, FTC warn companies for selling illegal, unapproved opioid cessation products using deceptive claims

The U.S. Food and Drug Administration and the Federal Trade Commission today posted joint warning letters to the marketers and distributors of 12...


Jan 23, 2018, 10:19 ET Medidas de precaución para preservar el buen estado de los alimentos en caso de cortes de energía eléctrica

Estamos en pleno invierno de 2018 y en muchas partes del país ya se registran condiciones climáticas extremas y cortes de energía eléctrica. De...


Jan 23, 2018, 10:02 ET Food Safety Precautions During Power Outages

It's winter of 2018 and many parts of the country are already experiencing extreme weather conditions and power outages. In fact, a power outage...


Jan 18, 2018, 16:10 ET Statement from FDA Commissioner Scott Gottlieb, M.D., on new policy steps for strengthening public warning and notification of recalls

Americans depend on the U.S. Food and Drug Administration to help ensure that the products they buy are safe. Last month, I committed the agency to...