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13 Mar 2010, 2:40 pm
Diabetics who wear insulin pumps appear more likely to experience problems from improper use than a device defect, members of a U.S. government advisory panel said on Friday.The Food and Drug Administration said problems with insulin pumps have occurred across the industry and asked the panel of outside experts for ways to minimize risks from malfunctions. [read post]
22 Dec 2009, 9:48 pm
Food and Drug Administration granted approval for Roche to market Mircera® in November, 2007 (it has already been approved in Europe and is sold in Austria, Sweden, Germany, the United Kingdom, and Norway) but the company has been under an injunction issued by Federal District Court Judge William G. [read post]
30 Sep 2013, 6:15 pm
The Food and Drug Administration (FDA) has warned that DMAA is potentially dangerous to health. [read post]
26 Mar 2016, 11:23 pm
Food and Drug Administration (FDA), and none of them worked. [read post]
11 May 2019, 9:15 am
In so holding, the Federal Circuit cited the Food and Drug Administration’s (FDA’s) skepticism of the efficacy of the methods as evidence supporting non-obviousness. [read post]
11 May 2022, 6:00 am
The April 16th, 2022, New York Times editorial entitled “Save America’s Patent System” recommends that the US Patent and Trademark Office (USPTO) be improved through collaboration with other agencies such as the Food and Drug Administration (FDA). [read post]
17 Feb 2016, 9:00 am
., Board Certified by The Florida Bar in Health Law The Food and Drug Administration (FDA) has great influence on a vast array of issues impacting the medical industry in the US The decisions it makes in 2016 will have a significant impact for health care providers and on the lives of many Americans. [read post]
4 Sep 2022, 8:47 pm
Food and Drug Administration will be discussing the intricacies that biotech and medtech independent inventors and startups face when securing intellectual property (IP) rights from the USPTO and when seeking regulatory approval from the FDA. [read post]
29 Mar 2024, 5:52 am
Food and Drug Administration (FDA), and the U.S. [read post]
6 Aug 2020, 1:15 pm
The latest exhibit—in the intellectual property space at least—is a letter to Health and Human Services (HHS) Secretary Azar, National Institutes of Health (NIH) Director Collins and Food and Drug Administration (FDA) Commissioner Hahn authored by California Attorney General Xavier Becerra and Louisiana Attorney General Jeff Landry. [read post]
23 Nov 2018, 7:55 pm
Fortunately, the Food and Drug Administration (FDA) announced earlier today that it has found the source of the contamination. [read post]
13 Jun 2016, 10:00 am
., Board Certified by The Florida Bar in Health Law On May 17, 2016, the United States Food and Drug Administration (FDA) published a draft guidance titled “Use of Electronic Health Record Data in Clinical Investigations” (Draft Guidance) which emphasizes interoperability and outlines other best practices for effectively using EHR data in FDA-regulated studies. [read post]
25 Sep 2021, 9:04 pm
Food & Drug Administration versus the U.S. [read post]
14 Apr 2024, 10:00 pm
Earlier this year, the US Food and Drug Administration (FDA) published new draft guidance substantially revising the agency’s previous guidance on the Establishment and Operation of Clinical Trial Data Monitoring Committees (DMCs). [read post]
28 Dec 2015, 10:37 am
A recent analysis by the Food and Drug Administration (FDA) had shown undeclared sibutramine and phenolphthalein in the Company's 3 dietary supplements.Sibutramine is a medication that assists with weight-loss by altering neurotransmitters within the brain. [read post]
28 May 2013, 10:00 am
., Board Certified by The Florida Bar in Health Law The US Food and Drug Administration (FDA) sent out a warning to health care professionals that steroid injections compounded by Main Street Family Pharmacy, LLC, in Tennessee, may be contaminated. [read post]
5 Apr 2014, 7:47 pm
A detailed report provided by the Food and Drug Administration (FDA) indicated that there was a 97 percent increase in the number of medical devices recalled annually from fiscal year 2003 to fiscal year 2012. [read post]
14 Apr 2024, 10:00 pm
Earlier this year, the US Food and Drug Administration (FDA) published new draft guidance substantially revising the agency’s previous guidance on the Establishment and Operation of Clinical Trial Data Monitoring Committees (DMCs). [read post]
2 Apr 2014, 7:41 am
The New York office of the Food and Drug Administration (FDA) sent warning letters earlier this month to three fish importers in Brooklyn and Queens over concerns their products were not being processed under the same conditions required of domestic producers.Their dried filefish, dried anchovy, and herring fillets were all refused entry into the US based on testing by FDA laboratories before the FDA inspected their facilities and sent them warning letters calling for… [read post]
7 Jan 2016, 11:46 am
Attorney's Office for the Central District of California in conjunction with the Food and Drug Administration, the company said.Source: http://www.foxnews.com/us/2016/01/06/chipotle-hit-with-subpoena-in-federal-criminal-investigation.html [read post]
