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21 Mar 2012, 9:53 am
" A spokeswoman for the F.D.A. declined to comment. [read post]
21 Mar 2012, 9:53 am
" A spokeswoman for the F.D.A. declined to comment. [read post]
5 Mar 2012, 12:49 pm
The handling of the ASR highlights how the F.D.A., by keeping its approval process confidential, may affect the health and safety of patients. [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]
22 Feb 2012, 6:53 pm
The generic drug industry tired of waiting for Congress to fully finance the F.D.A. [read post]
22 Feb 2012, 7:51 am
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]
10 Jan 2012, 3:22 pm
In September, an F.D.A. advisory panel recommended that such studies be required. [read post]
3 Jan 2012, 8:45 pm
Phelps – Over the New Year's Day weekend, The New York Times reported on the shortage of ADHD drugs, with this quote: “‘We have reached out to the D.E.A. and told them that there are shortage issues,’ said Valerie Jensen, associate director of the F.D.A. [read post]
24 Dec 2011, 9:44 am
Both device producers and their allies in Congress have maintained that any additional F.D.A. regulations would slow the development and marketing of innovative products that benefit patients. [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]
11 Dec 2011, 4:38 am
” So a committee that includes doctors who may stand to profit from getting the government to pay for useless medicines — or even have ties to the drug maker — can get to overrule the F.D.A. on how to spend scarce taxpayer money. [read post]
3 Dec 2011, 2:22 pm
If only five participants were needed to generate the scientific knowledge, then why would Geron and the F.D.A. have agreed to expose additional persons to the potential harms of trial participation? [read post]
22 Nov 2011, 2:45 am
“Sometimes, despite the hopes of investigators, patients, industry and even the F.D.A. itself, the results of rigorous testing can be disappointing,” Dr. [read post]
22 Nov 2011, 1:44 am
“Sometimes, despite the hopes of investigators, patients, industry and even the F.D.A. itself, the results of rigorous testing can be disappointing,” Dr. [read post]
12 Nov 2011, 7:05 am
Take a look at how thoroughly the Republican-controlled House of Representatives examined the issue: Since February, four House panels have held hearings on the impact of F.D.A. procedures on device approval. [read post]
10 Nov 2011, 2:41 am
Shortly after the F.D.A. advisory committee's negative vote, a panel of breast cancer doctors convened by the National Comprehensive Cancer Network, an organization of major cancer hospitals, reaffirmed that Avastin was 'an appropriate therapeutic option for metastatic breast cancer'...important because Medicare and UnitedHealthcare are supposed to pay for drugs listed in the cancer network's guidelines. [read post]
10 Nov 2011, 1:42 am
Shortly after the F.D.A. advisory committee’s negative vote, a panel of breast cancer doctors convened by the National Comprehensive Cancer Network, an organization of major cancer hospitals, reaffirmed that Avastin was ‘an appropriate therapeutic option for metastatic breast cancer’…important because Medicare and UnitedHealthcare are supposed to pay for drugs listed in the cancer network’s guidelines. [read post]
5 Nov 2011, 8:08 pm
Based on those study findings, the F.D.A. rejected that higher-dose formulation, known as Amplify, citing concern about cancer risks. [read post]
SORRY, I’M STILL SAYING “FASTER, PLEASE:” F.D.A. Officials, Hoping to Stave Off Critics, Point to I…
4 Nov 2011, 5:13 am
SORRY, I’M STILL SAYING “FASTER, PLEASE:” F.D.A. [read post]
26 Oct 2011, 10:03 am
The F.D.A. says its preliminary results suggest a 1.5-fold increased risk compared with other hormonal contraceptives, to about 10 women in 10,000 from 6 women in 10,000. [read post]
