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24 Oct 2016, 1:29 pm by Green and Associates
The ortho clinics denied knowing that the products were reimported.The government's position is that it wants to maintain the integrity of the health care system to ensure that patients receive drugs and devices that are safe and effective. [read post]
10 Feb 2007, 4:55 am by Ricky E. Bagolie
Ortho-McNeil and the FDA medical officer reviewing ORTHO EVRA disagreed about whether or not two cases of blood clots in the lungs (pulmonary embolus/PE) in young women participating in the pre-approval clinical trials were caused by the birth control patch. [read post]
28 Dec 2020, 6:38 am by Steven Koprince
The letter identified the deficiencies in Ortho-Clinical’s initial quotation and informed Ortho-Clinical that it could submit a revised quotation by May 15. [read post]
29 Jun 2018, 11:29 am by Stacey Lantagne
A recent case out of the Second Circuit, Ortho-Clinical Diagnostics Bermuda Co. [read post]
4 Apr 2014, 4:59 am
Ortho-McNeil Pharm., Inc., No. 3:09 oe 40028, 2014 U.S. [read post]
22 May 2010, 10:12 pm by Anthony Lake
The government claimed that Ortho-McNeil never applied for approval to use Topamax to treat psychiatric conditions and that there were no reliable clinical trials demonstrating that Topamax is safe and effective to treat psychiatric conditons. [read post]
15 Oct 2008, 4:20 pm
Clinical studies show Ortho Evra can double the risk of serious blood clots compared with the pill, according to the label. [read post]
30 Nov 2009, 9:00 pm
The FDA were troubled when they reviewed the results of Johnson & Johnson’s clinical trials because there seemed to be troubling discrepancies in the research. [read post]
8 Mar 2010, 1:51 pm by Tom Lamb
It seems that the findings presented in this January 2010 article come from a Phase IV Ortho Evra clinical trial known as "Relative Risks for Non-Fatal Venous Thromboembolism, Ischemic Stroke and Myocardial Infarction in Users of ORTHO EVRA(Norelgestromin and Ethinyl Estradiol Contraceptive Patch) Compared to Levonorgestrel-Containing Oral Contraceptives. [read post]
21 Feb 2011, 7:46 am
In May of 2010, Ortho McNeil Pharmaceutical, LLC, a subsidiary of Johnson & Johnson, pled guilty in U.S. [read post]
13 Feb 2018, 2:44 am by Nate Nead
[xiv] Ortho-Clinical Diagnostics – Originally the diagnostics division of Johnson & Johnson, Ortho- Clinical was bought out by The Carlyle Group in 2014 for $4.15B. [read post]
31 Jan 2013, 4:16 pm
Related Web Resources:Hip Implant Risks, Mayo Clinic Activities After Hip Replacement, Ortho Info More Blog Posts:First of DePuy Hip Lawsuits Go to Trial, Drug Injury Lawyers Blog, January 25, 2012 Johnson & Johnson Settles First Three DePuy Hip Implant Lawsuits for $600,000, Boston Injury Lawyer Blog, August 25, 2012 Zimmer KnexGen and DePuy Knee Implants Linked to Patient Injuries, Boston Injury Lawyer Blog, August 6, 2012 [read post]
19 Jul 2010, 1:12 pm by FDABlog HPM
Patent No. 5,053,407 (“the ‘407 patent”) covering Ortho McNeil’s (“Ortho’s”) LEVAQUIN (levofloxacin) is valid. [read post]