FDA

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Nasal Spray Derived From Party Drug Approved for Depression

Esketamine, for treatment-resistant depression, to be administered by experts

(Newser) - The FDA has approved a new fast-acting depression treatment derived from a party drug . Nasal spray esketamine from Johnson & Johnson's Janssen Pharmaceuticals contains an active portion of the ketamine molecule. As a generic anesthetic, ketamine or "Special K" is increasingly available for depression, but costs a pretty...

Scott Gottlieb Stepping Down From FDA

After almost 2 years leading the agency

(Newser) - Food and Drug Administration Commissioner Scott Gottlieb is stepping down after nearly two years leading the agency's response to a host of public health challenges, including the opioid epidemic, rising drug prices, and underage vaping. Health and Human Services Secretary Alex Azar announced in a statement Tuesday that Gottlieb...

FDA: Beware Letting Robots Operate on You

'Survival benefits to patients when compared to traditional surgery have not been established'

(Newser) - On the plus side: Operations performed using minimally invasive robotic devices can help keep blood loss, pain, and infections to a minimum, reduce scarring, and shorten recovery times. On the minus side, per the Food and Drug Administration: Using these devices for mastectomies and other surgeries for cancers hasn't...

FDA: Beware of Young Blood Transfusions

They're 'potentially harmful,' and claims aren't proven

(Newser) - The FDA has come down hard on young blood transfusions, touted by startups in several states as an anti-aging "cure" that can improve strength, memory, and even reverse the effects of Alzheimer's. Infusions of blood plasma from young donors into older patients "should not be assumed to...

Food Inspectors Heading Back to Work Without Pay

FDA inspections of 'high risk' items were to resume

(Newser) - The FDA says it will resume inspections of some of the riskiest foods—such as cheeses, produce and infant formula—that had been briefly halted as a result of the partial government shutdown. FDA Commissioner Scott Gottlieb said Monday that the agency is bringing back about 150 unpaid employees for...

Amid Increasing Drug Recalls, FDA Focuses on 2 Factories

Agency: Factories in China, India that made blood pressure drugs have equipment, process problems

(Newser) - With the significant number of drugs and drug ingredients made overseas, it's hard for the FDA to provide airtight oversight. But two plants in China and India that pump out oft-prescribed blood pressure and heart medications are now on the agency's radar after FDA tests revealed trace amounts...

Shutdown 'Puts US Food Supply at Risk'

FDA has suspended domestic inspections

(Newser) - The government shutdown has put America's food supply at risk despite the best efforts of the Food and Drug Administration, experts warn. The agency has had to suspend routine testing of most domestic food production facilities, though inspections of imports are continuing. Inspectors working without pay are continuing to...

FDA Narrows Its Romaine Lettuce Warning

Lettuce from outside parts of California not linked to outbreak

(Newser) - The Food and Drug Administration has narrowed its warning not to eat romaine lettuce . The agency now says the only growing areas linked to a recent E. coli outbreak are in the Central Coast region of northern and central California and romaine lettuce grown elsewhere is probably safe, USA Today...

Major Restrictions on Flavored E-Cigs Are Coming

FDA plans to rid them from convenience stores, gas stations to protect teens

(Newser) - The expected FDA crackdown on a youth vaping "epidemic" is on the horizon, with the New York Times and Washington Post reporting that most flavoured e-cigarettes will be banned from convenience stores and gas stations across the country as early as next week. Menthol and mint flavors will be...

Super-Potent Opioid Wins FDA Approval

Dsuvia will be tightly controlled, the FDA promises

(Newser) - It's called Dsuvia, and the potency of this opioid is hard to fathom: It's up to 1,000 times stronger than morphine and up to 10 times stronger than fentanyl, reports USA Today . Despite the worries of critics that it will add to the nation's opioid problem,...

The &#39;Magic&#39; in &#39;Shrooms Could Really Help You
The 'Magic' in 'Shrooms
Could Really Help You
new study
Oct 8, 2018 4:16 PM CDT

The 'Magic' in 'Shrooms Could Really Help You

New study says it can serve medicinal purposes

(Newser) - Want to quit smoking or alleviate depression? In a few years you might be taking the psychedelic "magic" in magic mushrooms—if the FDA ever agrees, the New York Times reports. Researchers from John Hopkins University suggest the FDA should reclassify psilocybin—the psychedelic drug in hallucinogenic mushrooms—to...

FDA May Take Drastic Moves to End Teen Vaping 'Epidemic'

Could ban sales if manufacturers don't comply with new requirement

(Newser) - Youth vaping is an "epidemic," as far as the FDA is concerned, and if manufacturers don't submit "robust" plans to prevent kids from getting their hands on flavored e-cigarettes, the agency will take action—possibly going so far as to order the flavored products off the...

New EpiPen Competitor Approved by FDA

Generic alternative should hit the market soon

(Newser) - Parents of children with serious allergies may soon get some relief when shelling out for a epinephrine auto-injector. The FDA has approved a generic alternative to Mylan Pharmaceuticals' widely used EpiPen and EpiPen Jr., reports CNN . While other name-brand injectors exist, this one, produced by Teva, is the first approved...

FDA Gives OK to Market Pregnancy- Prevention App

Natural Cycles says its technology is 93% effective, but there has been some controversy

(Newser) - "There's an app for that" is making further inroads in the contraceptives arena. USA Today reports the FDA has approved marketing for the Natural Cycles app, which claims it can help prevent pregnancy by telling a woman what days are best for avoiding sex (marked "red" days)...

Tainted Water Blamed for Deadly E. Coli Outbreak

Romaine lettuce outbreak is over, feds say

(Newser) - The worst E. coli outbreak in the US since 2006 is over, with five people dead and more than 200 sickened by tainted romaine lettuce, federal authorities say. The outbreak, which affected people in 36 states and caused at least 96 hospitalizations, was traced to the Yuma region in western...

FDA: Teething Remedies Can Have Deadly Side Effects

It wants the products taken off shelves

(Newser) - Federal health officials warned parents Wednesday about the dangers of teething remedies that contain a popular numbing ingredient and asked manufacturers to stop selling their products intended for babies and toddlers. The Food and Drug Administration said that various gels and creams containing the drug benzocaine can cause rare but...

Congress Passes 'Right-to-Try' Drug Bill

Law will let terminally ill patients bypass FDA

(Newser) - A "right-to-try" bill that allows terminally ill patients to request medication that hasn't been approved by the Food and Drug Administration has passed Congress and is expected to be signed by President Trump. The bill, which passed the Senate last August, sailed through the House Tuesday with a...

FDA Approves Potential Migraine Game-Changer

Monthly injection reduces migraine frequency without major side effects

(Newser) - "Progress, but not a panacea." So proclaims an editorial in journal JAMA on Aimovig, a first-of-its-kind drug purported to prevent chronic migraines without many side effects that was on Thursday approved by the FDA. The drug from Amgen and Novartis, and similar ones in their final stages, "...

FDA to E-Cigarette Companies: Stop the Kid-Friendly Packaging

It can lead to accidental ingestion, which can be fatal for children

(Newser) - The Food and Drug Administration is warning companies that make and sell e-cigarette liquid to stop using packaging that appeals to kids after a recent analysis found that more than 8,200 children under the age of 6 were exposed to e-cigarettes or liquid nicotine between January 2012 and April...

In a Big First, FDA Issues Mandatory Recall of Kratom

Recalls kratom products due to salmonella outbreak

(Newser) - A Las Vegas company was ordered to pull its herbal supplements off the market because some of its products tested positive for salmonella, part of a nationwide outbreak linked to the ingredient kratom. The Food and Drug Administration said Tuesday that it took the rare step of ordering the recall...

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