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9 Aug 2011, 9:53 am
In recent years there has been a lot of debate over the effectiveness of the Food and Drug Administrations' medical device review system, i.e., the 501(k) process. [read post]
5 Mar 2012, 12:49 pm
Food and Drug Administration (FDA) to reject Johnson & Johnson’s sale of an artificial hip in the U.S., but it didn’t stop the company from marketing it in Europe, according to a recent article by the New York Times. [read post]
7 Nov 2011, 2:56 pm
District Judge Richard Leon has today issued a preliminary injunction barring the Food and Drug Administration from requiring the tobacco industry to include new, graphic warnings on their cigarette packages. [read post]
30 Jun 2011, 4:30 am
We recently reported here that a South Carolina family-owned tomato farm had sued the United States Food and Drug Administration (FDA) in South Carolina federal court in Beaufort, alleging that the agency was negligent in its issuing of a 2008 nationwide tomato recall. [read post]
23 Oct 2023, 5:26 am
Food and Drug Administration (FDA) released guidance on cybersecurity in medical devices for quality system considerations and on premarket submissions. [read post]
5 Oct 2011, 3:02 am
Dow Jones Newswire reports that the US Food and Drug Administration says that Primatene Mist epinephrine inhalers, which are the only over-the-counter inhalers approved by the FDA, will not be produced or sold after December 31, because they use chlorofluorocarbons as propellant. [read post]
5 Jul 2012, 6:36 am
Food and Drug Administration, the Department of Agriculture and the Consumer Product Safety Commission, there were 2,363 recalls in 2011. [read post]
10 Dec 2011, 9:07 am
Pacific International Marketing (“Pacific”) is working with the Food and Drug Administration (“FDA”) and California Department of Public Health to coordinate a recall of Cilantro for potential contamination with Salmonella. [read post]
8 Apr 2010, 3:55 pm
The Food and Drug Administration has canceled its policy of giving rubber-stamp approval to marketing of powerful new radiation therapy equipment like linear accelerators. [read post]
7 Mar 2012, 8:55 am
A group of nine scientists and doctors recently sued the US government claiming that their personal Gmail accounts were under federal surveillance which led to harassment or dismissal for Food & Drug Administration (FDA) employees who were whistleblowers. [read post]
26 Jul 2011, 9:08 pm
The Food and Drug Administration (FDA) is considering changing the 510(k), accelerated device approval process, which currently provides medical device manufacturers a "fast track" in obtaining FDA approval to bring a new device to market after an Institute of Medicine Report (IOM) made the recommendation. [read post]
8 Apr 2017, 9:38 pm
Food and Drug Administration (FDA) to support an investigation of a dead bat that was found in a Fresh Express packaged salad purchased from a Walmart grocery store in Florida. [read post]
17 Oct 2011, 6:26 am
Food and Drug Administration (FDA) has updated its warning on the complications from surgical vaginal mesh implants to treat pelvic organ prolapse (POP). [read post]
6 Dec 2014, 9:07 am
Food and Drug Administration report by the Twin Falls Times-News, the daily newspaper located near the Idaho Chobani plant. [read post]
26 Apr 2011, 8:38 pm
Food and Drug Administration, has filed a complaint for permanent injunction against Daniel L. [read post]
29 Dec 2020, 5:59 pm
The New York Times – “The Food and Drug Administration on Tuesday issued an emergency authorization for the country’s first coronavirus test that can run from start to finish at home without the need for a prescription. [read post]
21 Jun 2013, 3:44 am
The Food and Drug Administration (FDA) is investigating a rise in problems with a robotic surgery device, including errors that may constitute medical malpractice. [read post]
26 May 2010, 2:59 am
Food and Drug Administration (FDA), which wanted to impose post-harvest restrictions on oysters during warm months.Future FDA action to control Vibrio vulnificus bacteria, recently the fastest growing among the causes of foodborne illness in America, will prohibit the sale of raw or live oysters from April to October, warm months in the Gulf.Rep. [read post]
9 Aug 2011, 2:59 am
A Texas company is recalling a single lot -- 248 cases -- of its Doggie Wishbone pet treats because they may be contaminated with Salmonella.Merrick Pet Care of Amarillo said the problem was identified through routine sampling by the Food and Drug Administration. [read post]
5 Nov 2018, 6:57 am
The piece notes the Food and Drug Administration’s approval of the Apple watch’s ECG app and irregular-rhythm notification feature, but stated the apps aren’t intended to replace traditional diagnosis methods. [read post]
