FDA Ramps Up Its Medical Device Cybersecurity Efforts
The U.S. Food and Drug Administration made two moves to address the cybersecurity of medical devices this week. On Tuesday, the agency announced increased coordination with the Department of Homeland Security on the matter, and today it released new guidelines for premarket submissions of medical devices.
“As innovation in medical devices advances and more devices...
U.S. Senate panel wants to question Hyundai, Kia over engine fire reports
WASHINGTON (Reuters) - The Senate Commerce Committee’s Republican chairman and ranking Democrat said on Wednesday they had asked top U.S. executives at Hyundai Motor Co (005380.KS) and Kia Motors Corp (000270.KS) to testify at a Nov. 14 hearing on reports of engine fires involving vehicles from the Korean automakers.
The call to testify comes after...
29 states touched by new salmonella outbreak, CDC says. And there’s even worse news
Yet another salmonella outbreak has sickened 92 cases in 29 states, the Centers for Disease Control announced Wednesday afternoon.
That’s the bad news. Now, for the worse news: Its origin might be widespread in that dietary basic — chicken.
The CDC says the 14th salmonella outbreak of 2018 traces to “raw chicken products from a variety...
Cost of blood pressure drug surges in U.S. after recall
NEW YORK (Reuters) - Prices for two dosages of the blood pressure drug valsartan rose more than any other drug in the United States in September, following a recall of much of the drug’s supply.
Chinese pharmaceutical ingredient manufacturer Zhejiang Huahai Pharmaceuticals recalled valsartan from consumers in the United States in July after finding traces...
Trump Rule Would Compel Drug Makers to Disclose Prices in TV Commercials
WASHINGTON — Over vehement objections by drug companies, the Trump administration proposed on Monday a new federal regulation that would require them to disclose the list prices of prescription drugs in their television advertisements.
The proposal sets the stage for a battle with the pharmaceutical industry, which said the requirement would be a form of...
Supreme Court Rejects Lead-Paint Maker Appeals in $400 Million Case
The U.S. Supreme Court rejected appeals from Sherwin-Williams Co. and Conagra Brands Inc., leaving intact a ruling that requires them to pay more than $400 million for lead-paint remediation in California.
The rebuff, issued without comment Monday, is a blow to business groups, which had called for high...
Viagra and vape? FDA warns e-cigarette company selling erectile dysfunction drug in e-liquid
The Food and Drug Administration issued a warning this week to an e-cigarette company that it says sold vaping e-liquid products containing the active ingredients in erectile dysfunction drugs Cialis and Viagra.
The FDA gave China-based HelloCig Electronic Technology Co. 15 days to address concerns that some of its products were "unapproved new drugs" being...
In crackdown, U.S. FDA seeks details on new electronic cigarettes
LOS ANGELES (Reuters) - Faced with a proliferation of new electronic cigarettes and a sharp rise in teen vaping, the U.S. Food and Drug Administration on Friday sent letters to 21 electronic cigarette manufacturers seeking information to assess whether the products are being marketed illegally.
An FDA rule banned the sale of new e-cigarette products...
Hyundai, Kia urged again to recall nearly 3 million crossovers, sedans for fire risk
WASHINGTON -- The Center for Auto Safety on Friday renewed calls for Hyundai Motor Co. and Kia Motors America to recall almost 3 million crossovers and sedans for potential noncollision fire risk.
The center wants the automakers to recall all 2011-14 Kia Sorrento, Kia Optima, Hyundai Sonata and Hyundai Santa Fe models, as well as...
Some dietary supplements contain potentially harmful drugs
(Reuters Health) - Potentially harmful pharmaceuticals not listed on product labels were found in more than 700 over-the-counter dietary supplements, researchers report.
The pharmaceuticals, which were found in so-called natural products, were most likely to appear in supplements marketed as weight loss aids, muscle builders and male libido enhancers, according to the report published in...
