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15 Jun 2012, 3:52 pm
In 2008, the United States Food and Drug Administration (“FDA”) issued a Public Health Notification (“PHN”) to warn patients about adverse effects related to urogynecologic use of surgical mesh. [read post]
26 May 2011, 5:14 pm
Food and Drug Administration’s (FDA) 510(k) approval process, which allows a medical device to be placed on the market without being subjected to clinical trials as long as the manufacturer can show that the device is “substantially equivalent” to a device already approved on the market. [read post]
15 Jun 2012, 3:52 pm
In 2008, the United States Food and Drug Administration (“FDA”) issued a Public Health Notification (“PHN”) to warn patients about adverse effects related to urogynecologic use of surgical mesh. [read post]
26 Jul 2012, 1:37 pm
FDA Adverse Effects Reports The Food and Drug Administration has received more than 3,800 reports of significant complications associated with transvaginal mesh patches. [read post]
28 Jun 2013, 3:23 am
A focus on plaque For Devous, the game changer came last year with the Food and Drug Administration’s approval of Amyvid, an amyloid imaging agent that allows researchers to track plaque in positron emission tomography scans. [read post]
2 Jul 2016, 9:03 am
Guidance from the Food and Drug Administration (FDA) and the Centers for Disease Control (CDC) continues to warn that consumers should refrain from consuming any raw products made with flour. [read post]
19 May 2010, 11:00 am
Although research is ongoing, the Food and Drug Administration (FDA) says that available scientific evidence--including World Health Organization (WHO) findings released May 17, 2010--shows no increased health risk due to radiofrequency (RF) energy, a form of electromagnetic radiation that is emitted by cell phones. [read post]
21 Sep 2018, 8:46 am
Companies in the United States and Europe are expected to begin treating patients with CRISPR-based therapies this year. [read post]
24 Dec 2011, 4:02 am
Food and Drug Administration launched a new initiative to prevent surgical fires, noting that although these flash fires are relatively rare events, they are also highly preventable. [read post]
19 Nov 2021, 6:08 am
In June of 2021, the United States Food and Drug Administration (FDA) issued a recall of millions of Philips CPAP, BiPAP, and ventilator machines. [read post]
30 Jun 2010, 9:00 am
Kellogg Company Voluntarily Recalls Select Packages ofKellogg's® Corn Pops®, Kellogg's® Honey Smacks®, Kellogg's® Froot Loops® and Kellogg's® Apple Jacks® Working in consultation with the United States Food and Drug Administration (FDA), Kellogg Company (NYSE:K) is implementing a voluntary recall of certain breakfast cereals due to an uncharacteristic off-flavor and smell coming from the liner… [read post]
14 Feb 2011, 9:00 am
Nearly 40 million mammograms are performed each year in the United States. [read post]
28 Dec 2011, 7:07 am
DePuy recalled the defective hip implants after the Food and Drug Administration (FDA) received about 400 complaints in two years from patients. [read post]
13 Aug 2015, 4:28 am
This can lead to medical devices being rushed to production, withholding information from the United States Food and Drug Administration (FDA) about safety concerns, and intentionally failing to conduct tests to determine long-term safety. [read post]
22 May 2015, 4:34 pm
Defendant points to the fact United States Food and Drug Administration (FDA) performed a study five years ago that found none of the cosmetics products they tested contained any evidence of asbestos. [read post]
16 May 2008, 12:08 pm
Notable leaders in attendance have included the Deputy Prime Minister of Malaysia, the Deputy Director General of the China State Food and Drug Administration, India's Director of the Department for Biotechnology, and South Africa's Minister of Agriculture. [read post]
1 Aug 2014, 11:48 am
In the complaint, plaintiffs rely on the United States Food and Drug Administration’s statement that a product is not “natural” if it contains color additives, artificial flavors, or synthetic substances. [read post]
20 Oct 2016, 12:04 pm
This newest lawsuit closely follows two consumer class actions launched against Theranos in Arizona and Northern California, as well as a litany of governmental investigations into the company, including by the United States Department of Justice, the Securities and Exchange Commission, the Centers for Medicare and Medicaid Services, and the Food and Drug Administration. [read post]
12 Oct 2015, 7:15 am
Food and Drug Administration, the FDA, took the unprecedented step of issuing a warning letter to SFNTC for violations of the 2009 Family Smoking Prevention and Control Act due to some of the claims that it is making about the American Spirit cigarette. [read post]
17 Jul 2016, 8:47 am
There were known problems involving a lack of safety testing, and the United States Food and Drug Administration (FDA) specifically ordered that the products not be shipped to surgeons because they were not approved for use. [read post]
