Search for: "F.D.A."
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15 Oct 2010, 4:38 pm
F.D.A. officials say the estimated 100,000 Americans using Meridia should stop taking the drug immediately and consult with their doctors. [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]
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]
12 Mar 2010, 12:42 pm
According to the New York Times, the F.D.A. has received about 300 complaints on the ASR involving patients in the United States who received it since 2008. [read post]
25 Nov 2008, 3:56 am
The F.D.A. has beefed up its inspections of Asian markets to make sure that infant formula and other products from China are not contaminated with melamine. [read post]
7 Apr 2009, 1:51 pm
"Last year, to win approval for a new heart cable from the Food and Drug Administration, the company agreed to provide the F.D.A. with future data from '10 experienced extraction centers,' according to agency records. [read post]
28 Oct 2008, 11:12 pm
The MammoSite system is among the thousands of devices the F.D.A. lets onto the market each year only cursory review and with no clear evidence that they help patients. [read post]
25 Jul 2016, 7:01 am
” As an alternative, the industry has proposed a cooperative effort between generic drug makers and brand-name companies “that would make the F.D.A. the final arbiter of label changes. [read post]
6 Feb 2009, 6:28 am
While the Obama administration can strengthen the F.D.A., Congress must reverse the Supreme Court's decision in order to make sure negligent device manufacturers can be held accountable. [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]
16 Mar 2010, 9:50 am
The F.D.A. has received about 300 complaints on the Depuy ASR hip implant involving patients in the United States who received it since 2008. [read post]
22 Aug 2011, 11:52 am
The NY Times article states that studies have shown that it may alter hormone regulation and that the "F.D.A. has already said that soap with triclosan is no more effective than washing with ordinary soap and water, a finding that manufacturers dispute. [read post]
18 Jan 2007, 2:55 am
Indeed, the requirements of pedigrees for pharmaceuticals (a list of prior owners) has still not been fully implemented despite being authorized by Congress in 1987.There is nothing in the bill about the most basic of safety issues, such as increased criminal penalties for counterfeiters, mandating pedigrees back to the manufacturer, and funding for the F.D.A. so that they can actually do random testing of drugs in the marketplace, recall them when needed, and do proper… [read post]
9 Apr 2013, 8:35 am
Officials of the F.D.A state that the death toll would be even higher but bed rails aren’t always listed as a cause of death by nursing homes. [read post]
3 Feb 2008, 4:33 am
Hutt warned that the FDA was "barely hanging on by its fingertips;" others testifying before the subcommittee suggested the agency lacked funds and staffing to do its job:In a hearing before a House Energy and Commerce subcommittee, members of the agency’s own scientific advisory board outlined the F.D.A. [read post]
2 Dec 2012, 2:57 pm
The F.D.A. and the Consumer Product Safety Commission are conducting a study on bed rails to determine what action is needed. [read post]
22 Aug 2011, 10:52 am
The NY Times article states that studies have shown that it may alter hormone regulation and that the "F.D.A. has already said that soap with triclosan is no more effective than washing with ordinary soap and water, a finding that manufacturers dispute. [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]
24 Jan 2019, 6:17 am
” He “plans to summon top executives of the companies to F.D.A. headquarters to explain how they will stick to their agreements given their new arrangement. [read post]
