Food and Drug Administration

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Trump: FDA Vaccine Rules Are a 'Political Hit Job'

With 2-month observation period, pre-election authorization is unlikely

(Newser) - The Trump administration has signed off on FDA guidelines for a thorough coronavirus vaccine review, which is likely to delay authorization until after Election Day, per the Wall Street Journal . Though officials had initially blocked the guidelines, per the AP , a senior administration official tells the Journal that the White...

FDA Chief: I Made a Mistake on Plasma Stat

Stephen Hahn overstated effectiveness of coronavirus treatment

(Newser) - Last weekend, FDA chief Stephen Hahn stood with President Trump and extolled the use of plasma as a coronavirus treatment. Trump said convalescent plasma "has proven to reduce mortality by 35%," and Hahn, while qualifying things a bit more, echoed the point. "What that means is—and...

Culprit in New Salmonella Outbreak: Red Onions

Nearly 400 Americans sickened in outbreak linked to Calif. company

(Newser) - Federal health officials say an outbreak of salmonella infecting nearly 400 people in more than 30 states has been linked to red onions, and identified a California company as the likely source. The Food and Drug Administration said in a statement on Friday that Thomson International Inc. of Bakersfield, Calif....

FDA Warns About Accuracy of Popular Virus Test

Abbott Labs is pushing back but will offer more guidance to clinicians handling the tests

(Newser) - More than 235,000 coronavirus tests by Abbott Laboratories have been distributed around the US in the hopes of better categorizing who's been infected where, per Axios . But the Food and Drug Administration is now issuing a warning about those tests, saying that in some cases they may be...

America OKs New Coronavirus Test
America OKs New
Coronavirus Test
May 9, 2020 2:30 PM CDT

America OKs New Coronavirus Test

The FDA grants emergency authorization

(Newser) - US regulators have approved a new type of coronavirus test that administration officials have promoted as a key to opening up the country, the AP reports. The Food and Drug Administration on Saturday announced emergency authorization for antigen tests developed by Quidel Corp. of San Diego. The test can rapidly...

2 More Dings Against Drug: an FDA Warning and a Study

Agency cautions hydroxychloroquine should only be used in very restricted settings

(Newser) - The drug once touted by President Trump as a possible "game changer" in the fight against the coronavirus has been the subject of more sobering headlines of late, and the newest one from the Food and Drug Administration doesn't help matters. Per Stat News , the FDA on Friday...

Just One Place Shocks Autistic Students. FDA Has Stepped In

Agency bans shock devices, just the 3rd item it's ever banned

(Newser) - Federal officials on Wednesday banned electrical shock devices used to discourage aggressive, self-harming behavior in patients with mental disabilities, the AP reports. The announcement from the FDA follows years of pressure from patient groups and mental health experts who have called the treatment outdated, ineffective, and unethical. The agency first...

FDA Looks Into Low Levels of Concerning Impurity in Zantac

No recall for now, FDA says

(Newser) - The FDA is evaluating the risk to people who take Zantac and its generic versions after a probable carcinogen was found in the heartburn medication. N-nitrosodimethylamine, also known as NDMA, is the nitrosamine impurity detected in low levels, CNN reports. The agency has been investigating such impurities in blood pressure...

FDA Unveils Graphic Cigarette Warning Labels

Tobacco companies blocked them once and are expected to try again

(Newser) - If the Food and Drug Administration gets its way, cigarette labels in the US are about to get pretty graphic. The agency has unveiled 13 proposed warning labels that would be prominently featured on cigarette packs and in cigarette advertising if approved, reports CNBC . The labels go beyond warning of...

New Treatment for Deadliest Strain of Tuberculosis Is Massively Successful

FDA approves new 3-drug regimen

(Newser) - Good news for those with the deadliest strain of tuberculosis: It no longer has to mean a death sentence. Scientists have discovered a cure for extensively drug-resistant TB, or XDR-TB, and on Wednesday, the FDA "effectively endorsed" it, the New York Times reports. Just a small percentage of people...

Despite 10 Years of Warnings, People Still Drink Dangerous 'Cure'

FDA: Taking sodium chlorite products like Miracle Mineral Solution is basically drinking bleach

(Newser) - It's OK to believe in miracles, but drinking bleach for your ailments isn't going to lead to one. That's effectively what people are doing when they quaff a product known as Miracle Mineral Solution, and other products like it that promise a cure for autism, cancer, HIV,...

FDA: Data Manipulated Before Approval of $2.1M Drug

Novartis could face civil, criminal penalties

(Newser) - US regulators want to know why Novartis didn't disclose a problem with testing data until after the Swiss drugmaker's $2.1 million gene therapy was approved. The Food and Drug Administration said Tuesday the manipulated data involved testing in animals, not patients, and it's confident that the...

First Postpartum Depression Drug: Effective, Cumbersome

Women felt improvement within 24 hours, but need to get it via IV for 60 hours

(Newser) - A groundbreaking treatment has been approved for what doctors say is a major medical condition that doesn't get talked about enough. The FDA has approved brexanolone, the first treatment specifically targeting postpartum depression, which will be sold as "Zulresso," USA Today reports. Doctors say it is much...

Birth Control Pills Recalled Due to Critical Packaging Error

Apotex mistake could lead women to miss pills, or to take placebos instead of active tablets

(Newser) - There's nothing wrong with the tablets themselves, but a nationwide recall of birth control pills has been announced by the Food and Drug Administration due to a packaging goof that could cause women to miss pills or take placebos, possibly leading to pregnancy, People reports. The FDA alert notes...

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...

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...

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,...

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