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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]
1 Nov 2009, 11:19 pm
But in one trial, known as Study 15, he noted, an e-mail message showed a company official saying "a great ‘smoke and mirrors' job' " had been done on a "buried" study in 1997, the year the F.D.A. approved Seroquel. [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]
12 Mar 2024, 7:33 pm
” In his ruling, he invalidated the F.D.A. [read post]
16 Mar 2013, 4:53 pm
F.D.A. [read post]
28 Jun 2014, 11:39 pm
(workers-compensation.blogspot.com)US Inspector General Wants More Disclosure By Back Surgeons Who Implant their Own Devices (workers-compensation.blogspot.com)FDA Closes Down Illegal On-Line Pharmacies (workers-compensation.blogspot.com)Rare Cancer Treatments, Cleared by F.D.A. but Not Subject to Scrutiny (workers-compensation.blogspot.com)FDA Orders Surveillance of Hip Implants (workers-compensation.blogspot.com)Metal-on-Metal Hip Implants: FDA Issues a Alert on Potential Risks… [read post]
30 Apr 2014, 12:32 pm
But with the Danish manufacturer of pentobarbital refusing to allow the drug to be used for executions, states started obtaining it from compounding pharmacies, "which mix small batches of drugs to order, and whose products are not approved by the F.D.A. [read post]
4 Mar 2009, 11:06 am
" The majority went on to conclude, "It is a central premise of the Food, Drug and Cosmetic Act and the F.D.A.'s regulations that the manufacturer bears responsibility for the content of its label at all times. [read post]
4 Apr 2012, 5:51 am
A recent New York Times article, “Hip Device Phaseout Followed F.D.A, Data Request” depicts a company so focused on corporate profitability that the company continued to allow their artificial hips to be implanted in patients after mounting data suggested problems with the devices including: premature failure, metal poisoning and other disabilities in patients. [read post]
15 Oct 2007, 12:04 pm
Schultz at the F.D.A. said the company's actions were an indicator of how much the industry had learned from the mistakes made in handling the Guidant malfunction. [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]
26 Jun 2011, 9:40 am
Under F.D.A. regulatory rules, most all-metal hips do not have to undergo clinical trials before sale. [read post]
21 Mar 2012, 5:37 pm
(Doctors may prescribe approved drugs for "off-label" uses, but drugmakers cannot endorse off-label uses without F.D.A. permission.) [read post]
10 Sep 2014, 1:50 pm
The New York Times recently highlighted FDA warnings in their sleep aid report: “The F.D.A. is looking at the data as it comes out and making sure we understand that many sleeping pills are not as benign as we assume,” said Dr. [read post]
19 Jun 2012, 1:52 am
At this point, the F.D.A. [read post]
31 Mar 2017, 1:50 pm
The same NYT news story provides some contextual information which seems to help understand that issue: A spokeswoman for the F.D.A., Stephanie Caccomo, said Tuesday’s announcement was made because “in 2016, there were several advances in the description of the disease and treatment recommendations, including recognition of the disease by the World Health Organization and publication of diagnosis and treatment guidelines by the Plastic Surgery Foundation and National… [read post]
1 Mar 2011, 4:15 am
The F.D.A., for instance, has expressed that it is baffled as to why company executives have not been able to identify, prevent, or explain the recent emergence of problems that plague the medical manufacturer's products. [read post]
10 Sep 2011, 10:02 am
The medical advisers did not press the issue as strongly as the F.D.A. staff itself did in a 45-page report issued on Wednesday. [read post]
10 Apr 2015, 7:55 am
Michael Jacobson, executive director of the Center for Science in the Public Interest, said, “To have former officials in the supplement industry become the chief regulators of that industry at the F.D.A. is like the fox guarding the hen house. [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]