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16 May 2012, 10:07 pm
Specifically, two major clinical trials are being funded. [read post]
16 May 2012, 8:12 pm
The sample size was also apparently small—only eight participants;In another study, the data was altered and incomplete: some participants actually gained weight, but were falsely reported as having lost weight;Data was missing and/or not collected for some participants in one study;Unfortunately for Skechers, these irregularities in the clinical studies evolved into large-dollar liability. [read post]
15 May 2012, 8:55 am
“As the agreed statement of facts filed in court today demonstrates, Abbott promoted Depakote to control behaviors in elderly dementia and schizophrenia patients without significant evidence of its effectiveness for that use, and even after clinical data established that it was not effective,” said Timothy Heaphy, U.S. [read post]
2 May 2012, 4:47 am
Analysis says many clinical trials are small, have quality issues. [read post]
1 May 2012, 6:03 am
Acuity Specialty Products Group, Inc., 664 F.Supp. 2d 137 (D. [read post]
29 Apr 2012, 1:54 pm
©2012 Amaxx Risk Solutions, Inc. [read post]
17 Apr 2012, 6:36 pm
The PCS settlement follows an extensive OCR investigation of a report that PCS posted clinical and surgical appointments for its patients on a publically accessible Internet-based calendar. [read post]
12 Apr 2012, 10:56 am
The Supreme Court emphatically held in Medtronic, Inc. v. [read post]
11 Apr 2012, 11:14 am
King Bio Pharmaceuticals, Inc., 107 Cal. [read post]
10 Apr 2012, 3:53 pm
FDA also states in the petition response that the Agency approved three ANDAs for generic VANCOCIN, including one from Akorn, Inc. [read post]
2 Apr 2012, 10:46 am
FDA is convening this committee to seek expert scientific and clinical opinion on the risks and benefits of these types of devices based on available scientific data. [read post]
2 Apr 2012, 10:34 am
FDA is convening this committee to seek expert scientific and clinical opinion on the risks and benefits of these types of devices based on available scientific data. [read post]
1 Apr 2012, 11:22 am
There is little safety data with the new drugs on big groups of patients, including the elderly, people with impaired kidney function and patients with significant valvular heart disease. [read post]
25 Mar 2012, 1:40 pm
©2012 Amaxx Risk Solutions, Inc. [read post]
21 Mar 2012, 5:40 pm
Another draft guidace on “Submission of Clinical Pharmacology Data as Evidence of Biosimilarity for Biologics and Protein Products” is on FDA’s guidance agenda for later this year.) [read post]
19 Mar 2012, 9:07 am
The suit was filed against Accretive Health Inc. [read post]
15 Mar 2012, 5:29 am
Beth Israel is a component of Continuum Health Partners, Inc. [read post]
15 Mar 2012, 5:00 am
Amgen Inc., 272 Fed. [read post]
Parker McDonald Reports on the MHRA Releasing New Advice for Metal-On-Metal Hip Replacement Patients
5 Mar 2012, 1:39 pm
This recall came after data from the National Joint Registry of England and Wales indicated that the five-year failure rate of these products is approximately 13 percent, or 1 in 8 patients. [read post]
Parker McDonald Reports on the MHRA Releasing New Advice for Metal-On-Metal Hip Replacement Patients
5 Mar 2012, 1:35 pm
This recall came after data from the National Joint Registry of England and Wales indicated that the five-year failure rate of these products is approximately 13 percent, or 1 in 8 patients. [read post]
