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28 Feb 2009, 8:37 am
The drugs are currently approved by the Food and Drug Administration only for adults. [read post]
26 Feb 2009, 8:23 am
Food and Drug Administration has prohibited Ranbaxy Laboratories Ltd., India's largest drug manufacturer, from introducing new generic drugs from one of its factories after it falsified data about products' shelf life. [read post]
24 Feb 2009, 6:50 pm
The devices were manufactured by the defendant and others in a San Diego location, which he failed to register with the Food and Drug Administration (FDA) as a device manufacturing establishment. [read post]
23 Feb 2009, 11:17 am
Wyeth then appealed to the United States Supreme Court. [read post]
23 Feb 2009, 2:41 am
The stent had not been approved by the Food and Drug Administration when implanted. [read post]
21 Feb 2009, 2:16 pm
The problem is that the Food and Drug Administration has been criticized as providing "spotty" oversight and not protecting the public the way they are supposed to. [read post]
21 Feb 2009, 11:41 am
In other cases, judges have been known to exclude animal studies of product exposure as being unreliable despite the fact that animal studies are routinely used in Food and Drug Administration (FDA) and Occupational Safety and Health Administration (OSHA) risk assessments. [read post]
21 Feb 2009, 7:05 am
Many Georgia consumers have been impacted by a recent Supreme Court ruling granting immunity from lawsuits to medical device makers for products approved by the Food and Drug Administration (FDA). [read post]
19 Feb 2009, 12:55 am
The District Court denied defendants' motion to dismiss and granted the plaintiffs' motion for class certification, but shortened the class period by more than one year, finding that investors could not have reasonably relied on defendants' alleged misrepresentations after February 1, 2006, the date the Food and Drug Administration ("FDA") staff published a report on a clinical study of Celebrex, a popular anti-inflammatory medication. [read post]
17 Feb 2009, 11:45 am
Soon thereafter, Abbott filed two more derivative patent applications and its New Drug Application ("NDA") with the Food and Drug Administration ("FDA"). [read post]
17 Feb 2009, 6:53 am
In particular, the Food and Drug Administration (“FDA”) denied the Defendants’ request to market Celebrex without the GI warning label required for other NSAIDs. [read post]
12 Feb 2009, 10:42 am
July 21, 1998); United States v. [read post]
11 Feb 2009, 2:15 am
The Food and Drug Administration has announced a public meeting on BPA to be held on February 24, 2009, by the Science Board to the FDA. [read post]
10 Feb 2009, 8:08 pm
Elsewhere in the United States, however, several fatalities are being linked to this particular strain of salmonella, which is being spread because numerous food items contain the tainted peanut products. [read post]
10 Feb 2009, 12:28 pm
These products are classified as Schedule II narcotics and already are restricted according to rules jointly administered by the Food and Drug Administration and the Drug Enforcement Agency. [read post]
10 Feb 2009, 7:38 am
Soon thereafter, Abbott filed two more derivative patent applications and its New Drug Application ("NDA") with the Food and Drug Administration ("FDA"). [read post]
9 Feb 2009, 11:32 pm
There were two pieces of art, and the split was 35/15.A press release noted:The Study was won by Article One community members, called Advisors, from the United States. [read post]
9 Feb 2009, 5:10 am
The United States District Court for the Central District of California recently held that state law consumer fraud claims and federal fraud claims pursuant to the Racketeer Influenced and Corrupt Organizations Act (“RICO”) are not preempted by the federal Food, Drug and Cosmetics Act (“FDCA”) if such claims are based on specifically identifiable false or misleading representations or material omissions. [read post]
9 Feb 2009, 5:00 am
The Second Circuit remanded the case to the United States District Court for the Southern District of New York for further proceedings.The case involves 88 Nigerian families who allege that Pfizer tested a new antibiotic, Trovafloxacin Mesylate (“Trovan”), on children in a Nigerian hospital during an outbreak of bacterial meningitis in 1996 in an attempt to gain the approval of the United States Food and Drug… [read post]
5 Feb 2009, 10:00 pm
A Food and Drug Administration (FDA) advisory panel voted 14-12 last Friday to recommend withdrawing Darvon after a hearing on its risks and beneifts. [read post]