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26 Jan 2011, 9:02 am
For reasons that are unclear, the F.D.A. eventually did allow it into the country. [read post]
23 Jan 2011, 5:19 pm
The problem stems from the fact that current rules do not require device producers to notify the F.D.A. when they bundle together components from approved and unapproved devices, Mark Melkerson, an FDA official, acknowledged. [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]
23 Dec 2010, 2:43 am
Wolfe, the director of the Public Citizen’s Health Research Group and a longtime F.D.A. critic. [read post]
20 Dec 2010, 3:29 am
So she called the F.D.A. and sued. [read post]
19 Dec 2010, 1:30 pm
And that number may rise as more and more clinical trials – central to a drug’s approval process and as an estimate of the efficacy of a particular drug – are done overseas where trials are cheap and out of reach from the F.D.A. [read post]
18 Dec 2010, 3:12 am
Further, "In 2008 alone, according to the inspector general’s report, 80 percent of the applications submitted to the F.D.A. for new drugs contained data from foreign clinical trials. [read post]
17 Dec 2010, 5:19 am
New iterations of device designs already used on patients typically receive scant scrutiny from the F.D.A. before going to market. [read post]
16 Dec 2010, 6:50 am
The F.D.A. [read post]
10 Dec 2010, 3:40 am
An excerpt:One big factor in the shift of clinical trials to foreign countries is a loophole in F.D.A. regulations: if studies in the United States suggest that a drug has no benefit, trials from abroad can often be used in their stead to secure F.D.A. approval. [read post]
6 Dec 2010, 10:08 am
Additionally, if a U.S. study finds a drug has no benefit, a foreign study can be used to secure F.D.A. approval. [read post]
6 Dec 2010, 6:06 am
Will that number go up, now that most clinical trials are conducted overseas-on sick Russians, homeless Poles, and slum-dwelling Chinese-in places where regulation is virtually nonexistent, the F.D.A. doesn't reach, and "mistakes" can end up in pauper's graves? [read post]
6 Dec 2010, 6:06 am
Will that number go up, now that most clinical trials are conducted overseas-on sick Russians, homeless Poles, and slum-dwelling Chinese-in places where regulation is virtually nonexistent, the F.D.A. doesn't reach, and "mistakes" can end up in pauper's graves? [read post]
29 Nov 2010, 11:13 am
Moonshot ’69, Beer With Caffeine, Is Caught in F.D.A. [read post]
19 Nov 2010, 5:35 pm
Estrella’s supporters appear to have toward the F.D.A. [read post]
17 Nov 2010, 4:59 am
These two conclusions . . . are the result of a yearlong investigation by the F.D.A. into hundreds of radiation overdoses in 2008 and 2009 that occurred during a specific diagnostic test for a stroke, called a CT brain perfusion scan. [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]
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]
29 Oct 2010, 10:52 am
Botox is approved by the F.D.A. to treat uncontrolled blinking; crossed eyes; certain neck muscle spasms; excessive underarm sweating; and stiffness associated with muscle spasticity in the elbows and hands. [read post]
27 Oct 2010, 12:36 pm
” The fact that the F.D.A. has not approved foreign sources of sodium thiopental, he said, suggested that “it’s very likely that a petitioner will be able to make this showing in a case where there is more time to litigate the issue than there was in the Arizona case. [read post]
