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31 Aug 2011, 3:44 am
It is not immediately clear what impact, if any, the report will have or how its findings can be adopted; the recommendations are only advisory to the F.D.A. [read post]
2 Mar 2008, 12:33 am
Herrmann, who writes a blog about these issues (druganddevicelaw.blogspot.com), said Thursday that the decision put the onus on medical device companies and the F.D.A. to prove they can protect patients without the threat of product-injury lawsuits. [read post]
17 Dec 2011, 9:56 am
The new proposal would not require added premarket testing of such implants but would broaden the F.D.A’s postapproval oversight by giving it the authority to mandate that companies collect data on device performance. [read post]
25 Jan 2010, 3:50 pm
Botox death case heads to trial, OC Register, January 25, 2010 F.D.A. [read post]
24 Dec 2010, 3:06 am
Wolfe, the director of the Public Citizen’s Health Research Group and a longtime F.D.A. critic. [read post]
20 Feb 2010, 9:15 am
Despite the findings of heart damage, the drug stayed on the market when "an F.D.A. oversight board voted 8-7" too keep it on the market. [read post]
3 Apr 2007, 2:55 pm
On Thursday, the F.D.A. notified the company that it had decided that Zelnorm should be withdrawn. [read post]
22 Jul 2010, 9:55 am
The F.D.A. has split on whether to withdraw Avandia from the market or not. [read post]
26 Mar 2012, 6:06 am
A recent New York Times article, “Hip Device Phaseout Followed F.D.A, Data Request” depicts a company so focused on corporate profitability that the company continued to allow their artificial hips to be implanted in patients after mounting data suggested problems with the devices including: premature failure, metal poisoning and other disabilities in patients. [read post]
9 Nov 2007, 9:44 am
" The new labels came after the F.D.A. held two advisory committee meetings to consider the safety of the drugs. [read post]
23 Feb 2012, 1:01 pm
According to The New York Times, in a confidential letter sent to Johnson & Johnson, the F.D.A. told the company that studies and clinical data submitted to gain approval in the United States were inadequate to determine its effectiveness and safety. [read post]
4 Nov 2010, 3:54 am
But now the F.D.A. and drug regulators in Europe are restricting Avandia’s use because it appears to increase heart risks. [read post]
26 Jan 2009, 2:29 pm
"If there is a record of habitual violations of food safety standards, the F.D.A. should have initiated strenuous enforcement action," said Tony Corbo, a senior lobbyist with the group. [read post]
15 Jul 2010, 7:46 am
The F.D.A. often takes the advice of its advisory panels, but experts say they cannot predict its action in this case due to the split nature of the vote. [read post]
21 Jul 2012, 1:09 pm
As cautioned by the F.D.A., “After taking Zolpidem Tartate Tablets, you may get up out of bed while not being fully awake and do an activity that you do not know you are doing. [read post]
14 Aug 2012, 3:58 pm
He wrote that "Congress and the F.D.A. retain the authority to change the law and regulations if they so desire. [read post]
3 Nov 2010, 3:45 am
But now the F.D.A. and drug regulators in Europe are restricting Avandia’s use because it appears to increase heart risks. [read post]
26 Sep 2009, 8:32 am
The company also said it had responded to the F.D.A.'s questions about manufacturing practices, which it said it took very seriously. [read post]
15 Oct 2009, 6:00 am
When questioned about their alleged conflict of interest in endorsing the approval of Menaflex all four members of Congress denied that ReGen's political contributions had played any role in their efforts on its behalf with the F.D.A. and said they were merely doing their jobs by trying to help a company. [read post]
22 Jul 2006, 12:37 pm
The FDA's rule is here.)But it is apparently perfectly okay for a pharmaceutical company to pay a physician to promote the off-label use of the company's approved drug or, as the Times article puts it: "Despite the F.D.A.'s constraints on drug makers, though, the companies are allowed to hire independent doctors to talk to other physicians about their medicines. [read post]
