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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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17:32 ET FDA approves automated insulin delivery and monitoring system for use in younger pediatric patients

The U.S. Food and Drug Administration today expanded the approval of the MiniMed 670G hybrid closed looped system, a diabetes management device...


15:40 ET FDA approves first continuous glucose monitoring system with a fully implantable glucose sensor and compatible mobile app for adults with diabetes

The U.S. Food and Drug Administration today approved the Eversense Continuous Glucose Monitoring (CGM) system for use in people 18 years of age and...


Jun 19, 2018, 15:02 ET Statement from Douglas Throckmorton, M.D., deputy center director for regulatory programs in FDA's Center for Drug Evaluation and Research, on the agency's response to ongoing drug shortages for critical products

Among the biggest challenges health care providers and patients face are shortages of medically necessary medications. These shortages greatly...


Jun 19, 2018, 11:07 ET Statement from FDA Commissioner Scott Gottlieb, M.D., on new guidance to help manufacturers implement protections against potential attacks on the U.S. food supply

In the U.S., we enjoy one of the safest food supplies in the world. The FDA takes its responsibility to protect the U.S. food supply very...


Jun 19, 2018, 10:00 ET Los tatuajes de "henna negra" pueden ponerlo en riesgo

La temporada de vacaciones de verano ha llegado… es el momento de ir a la playa y, tal vez, permitirse un poco de diversión inofensiva. ¿Qué decir...


Jun 19, 2018, 10:00 ET "Black Henna" Tattoos May Put You at Risk

Summer vacation season is here… time to hit the beach and perhaps indulge in a little harmless fun. What about getting a black henna temporary...


Jun 14, 2018, 16:48 ET FDA approves first generic versions of Suboxone sublingual film, which may increase access to treatment for opioid dependence

The U.S. Food and Drug Administration today approved the first generic versions of Suboxone (buprenorphine and naloxone) sublingual film (applied...


Jun 14, 2018, 09:32 ET Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency's efforts to better equip consumers with nutritional information about dietary fiber in their food

Increasingly, Americans are seeking healthy food options, whether they're eating out or dining at home. Their ability to choose healthy foods...


Jun 13, 2018, 12:03 ET FDA Fast Facts: FDA works with partners to investigate Salmonella outbreak linked to pre-cut melon

The U.S. Food and Drug Administration and the Center for Disease Control and Prevention, along with state and local officials, are investigating a...


Jun 12, 2018, 11:48 ET Statement from FDA Commissioner Scott Gottlieb, M.D., on new agency efforts to advance the patient voice in medical product development and FDA regulatory decision-making

Over the past decade, advances in our understanding of the basic biology of serious and life-threatening diseases has led to the development and...


Jun 12, 2018, 10:51 ET Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA's efforts to foster discovery and development of new tools to fight antimicrobial-resistant infections

The increase in serious antimicrobial drug resistant infections is a critical public health concern and a growing threat to patients. According to...


Jun 12, 2018, 09:47 ET Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to advance medical product communications to support drug competition and value-based health care

We're living in a time of unparalleled scientific advancement. Innovative medical treatments continue to be developed at an astonishing pace and...


Jun 08, 2018, 17:13 ET Federal judge enters consent decree against Delta Pharma

U.S. District Judge Neal B. Biggers for the Northern District of Mississippi entered a consent decree of permanent injunction today between the...


Jun 07, 2018, 13:43 ET Statement from FDA Commissioner Scott Gottlieb, M.D., on 2017 National Youth Tobacco Survey results and ongoing FDA efforts to protect youth from the dangers of nicotine and tobacco products

We're encouraged by declines in overall youth tobacco use over the last several years reflected in the 2017 National Youth Tobacco Survey....


Jun 06, 2018, 16:39 ET FDA seeks permanent injunction against company selling unapproved hand sanitizers that claim to prevent infections from numerous pathogens

The U.S. Food and Drug Administration today filed a complaint against Innovative BioDefense, Inc. of Lake Forest, California, and Colette Cozean,...


Jun 05, 2018, 14:44 ET FDA and USDA announce key step to advance collaborative efforts to streamline produce safety requirements for farmers

As part of the U.S. Food and Drug Administration and the U.S. Department of Agriculture's ongoing effort to make the oversight of food safety...


Jun 05, 2018, 12:38 ET FDA takes action against 53 websites marketing unapproved opioids as part of a comprehensive effort to target illegal online sales

The U.S. Food and Drug Administration today announced that it has warned nine online networks, operating a total of 53 websites, that they must...


Jun 05, 2018, 12:37 ET FDA warns companies to stop selling dangerous and illegal pure and highly concentrated caffeine products

The U.S. Food and Drug Administration has issued warning letters to the parties responsible for liquidcaffeine.com and Dual Health Body and Mind...


Jun 04, 2018, 16:58 ET FDA approves first biosimilar to Neulasta to help reduce the risk of infection during cancer treatment

The U.S. Food and Drug Administration today approved Fulphila (pegfilgrastim-jmdb) as the first biosimilar to Neulasta (pegfilgrastim) to decrease...


Jun 04, 2018, 10:06 ET Statement from FDA Commissioner Scott Gottlieb, M.D., on proposed modernization of FDA's drug review office

Scientific and medical advances are giving the FDA more opportunities to more fully address diseases and illness. Whereas one time all that...


May 31, 2018, 14:23 ET Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA's work to mitigate shortages of intravenous drugs, shorten supply disruptions and better predict vulnerabilities

Without question, one of the most frustrating challenges that health care providers and patients must contend with is when a drug that's medically...


May 31, 2018, 10:00 ET Statement from FDA Commissioner Scott Gottlieb, M.D., on new policies to reduce the ability of brand drug makers to use REMS programs as a way to block timely generic drug entry, helping promote competition and access

Our system for developing new drugs is based on a careful equilibrium enshrined in legislation by Congress that seeks to balance access with...


May 30, 2018, 15:41 ET Statement from FDA Commissioner Scott Gottlieb, M.D., on federal preparedness and FDA's response efforts to the Ebola virus outbreak in the Democratic Republic of Congo

Time and time again, we're reminded that disease knows no borders. While our globalized world and modern transportation helps promote economic...


May 30, 2018, 15:26 ET FDA approves first artificial iris

The U.S. Food and Drug Administration today approved the first stand-alone prosthetic iris in the United States, a surgically implanted device to...


May 30, 2018, 13:35 ET Statement from FDA Commissioner Scott Gottlieb, M.D., on the signing of the Right to Try Act

For patients with serious or immediately life-threatening diseases, the FDA remains committed to enhancing access to promising investigational...