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20 Aug 2010, 1:40 pm
David Graham, an F.D.A. medical officer, made an impassioned presentation at the advisory hearing arguing that the study should be stopped because thousands of patients in the trial were being exploited. [read post]
9 Aug 2010, 7:38 am
The problem is that there is no F.D.A. [read post]
1 Aug 2010, 7:58 pm
NYTimes: F.D.A. [read post]
27 Jul 2010, 4:02 am
If the F.D.A. decides to follow the committee recommendation, it would not affect marketing of the drug for brain, lung, colon and kidney cancer. [read post]
26 Jul 2010, 10:02 am
The F.D.A. indentified other common problems causing emergency department visits by children and teens. [read post]
22 Jul 2010, 12:38 pm
Dangerous drugs seem to have been rushed to market with F.D.A .approval during the early part of this century. [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]
17 Jul 2010, 7:10 pm
The New York Times reports that the F.D.A. restricts drug's sales only when a drug offers a unique benefit, something no study has shown about Avandia. [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]
14 Jul 2010, 12:57 pm
Get a complete look at both days of the meeting by checking out the first day of news and opinion.Federal panel: Evidence shows increased health risks associated with AvandiaAvandia debate spotlights key FDA decision makersAvandia, GSK, FDA, Angels & DemonsAvandia increases risk of heart problems: panelGlaxo Said to Pay $460 Million to Settle Avandia Damage SuitsBlogging the F.D.A. [read post]
13 Jul 2010, 9:38 am
" Surprisingly, the issue of whether to withdraw Avandia as a dangerous drug from the market has split the F.D.A., with some regulators arguing in favor of keeping the drug on the market despite the risks. [read post]
1 Jul 2010, 6:30 am
The company promoted the use of the drugs for medical conditions that the F.D.A. had not approved them for other uses and doses. [read post]
31 May 2010, 11:01 pm
Between 1988, the year after Prozac was approved by the F.D.A., and 2000, adult use of antidepressants almost tripled. [read post]
30 Apr 2010, 10:03 am
Most patients, according to the F.D.A., can rest in nursing homes safely without bed rails, as long as the patients are monitored often. [read post]
27 Apr 2010, 3:50 am
F.D.A. officials said, however, that based on their review of pump complaints they thought many deaths and injuries related to the devices were less the result of user error than of product design and engineering.For example, agency officials said that some pumps were prone to key bounce, a problem in which defective software interprets a single keystroke as two separate presses of that key. [read post]
21 Apr 2010, 6:59 am
Amols, chief of clinical physics at Memorial Sloan-Kettering Cancer Center in New York, said the F.D.A. [read post]
13 Apr 2010, 4:54 pm
F.D.A. [read post]
8 Apr 2010, 3:55 pm
Amols, chief of clinical physics at Memorial Sloan-Kettering Cancer Center in New York, as saying the more serious problems stem from shortcomings in staffing, personnel competency and hospital quality assurance programs: “I’d also caution that however commendable tougher standards for premarket approval of software may be, its not clear that F.D.A. has the expertise to police this,” Dr. [read post]
3 Apr 2010, 8:43 am
Congress has passed the issue on to the F.D.A., which will have a stated two-year deadline to propose new regulations. [read post]
