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7 Feb 2011, 9:30 am
The FDA reviewed data on the safety and effectiveness of Makena in a multicenter randomized double-blind clinical trial. [read post]
11 Sep 2011, 9:50 pm
Like other medical devices, including the DePuy hip implant that has been recalled, surgical mesh systems were allowed by the FDA to come onto the market without clinical data which proved that the devices were safe and effective. [read post]
11 Sep 2011, 9:50 pm
Like other medical devices, including the DePuy hip implant that has been recalled, surgical mesh systems were allowed by the FDA to come onto the market without clinical data which proved that the devices were safe and effective. [read post]
6 Apr 2020, 9:05 pm
If SVF is not restricted under the FDCA, this could facilitate data collection in the clinical setting, effectuating the standardization of SVF processing methods and the development of best practice standards in an industry that is likely to expand. [read post]
17 Jun 2022, 2:09 pm
Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993), legal scholars, judges, and lawyers have struggled with the structure and validity of expert opinion on specific causation. [read post]
27 Oct 2016, 7:02 am
The SEC alleges that one of them obtained confidential clinical and business data about other pharmaceutical firms being considered by his company for potential acquisitions and business relationships, and he used the nonpublic information to trade in their stocks. [read post]
1 Jul 2013, 5:30 am
http://t.co/nans1qay6k -> Computer and Internet Law Updates for 2013-06-26 http://t.co/0rd9a1Odp7 -> Canadian green patents rocketing http://t.co/1hvkw2oKvU -> TekSavvy illegal downloading case risks bogging down legal system, judge says http://t.co/qdSkxVCWmc -> Music Canada AGM 2013 http://t.co/bURqOv4RAe -> Facebook, Apple, Microsoft, Skype and Yahoo Hit With Prism Data Protection Complaints In Europ http://t.co/33HJWkmvea -> McCarthy Tétrault, the only firm… [read post]
15 Mar 2016, 5:09 pm
Among other things, management described the clinical trial data as “nothing short of stunning” and told analysts that Sanofi was “in [a] good position to launch Lemtrada. [read post]
27 Jan 2007, 11:25 am
Patients with a history of such events should be carefully monitored clinically and with appropriate radiographic and laboratory studies while taking pergolide.If you have additional questions regarding Permax, you may contact Amarin Pharmaceuticals, Inc., our US licensee for Permax, at 1-800-969-4877.Sincerely,Valerie E. [read post]
10 Mar 2011, 5:00 am
” The complaint focuses on two public companies for which Silverman received non-public information through Guidepoint consultants: Ariad Pharmaceuticals, Inc. and Questcor Pharmaceuticals Inc. [read post]
10 Mar 2011, 5:00 am
The complaint focuses on two public companies for which Silverman received non-public information through Guidepoint consultants: Ariad Pharmaceuticals, Inc. and Questcor Pharmaceuticals Inc. [read post]
4 Apr 2017, 8:00 am
Medtronic, Inc. [read post]
14 Jun 2016, 6:02 pm
Stormans, Inc. v. [read post]
23 Jun 2009, 2:44 pm
The FDA based its review on postmarket reports and clinical trial data submitted by the manufacturers of the drugs.... [read post]
19 Jun 2022, 4:44 pm
The authors also point to a talc ovarian cancer case as exemplifying the use of clinical data to supplement a relative risk below two.[9] The cited case, however, involved expert witnesses who claimed a relative risk greater than two for the tortogen, and who failed to show how clinical information (such as the presence of talc in ovarian tissue) made the claimant any more likely to have had a cancer caused by talc. [read post]
16 Jun 2011, 7:07 am
Food and Drug Administration today announced it has begun a safety review of the diabetes drug Actos (pioglitazone), after receiving preliminary results from a long-term observational study designed to evaluate the risk of bladder cancer associated with use of this drug.The preliminary results are based on five-year data from an ongoing, 10-year observational study by the manufacturer, Takeda Pharmaceuticals North America Inc., San Diego. [read post]
27 Aug 2014, 4:35 pm
In fact, health care worker have “remarkably high rates of injuries due to assaults by patients,” according to a January 2012 research brief by the National Council on Compensation Insurance, Inc., (NCCI), a data collection bureau that focuses on workers’ compensation matters. [read post]
9 Nov 2012, 2:15 pm
These data were presented today at the American Heart Association's Scientific Sessions 2012. [read post]
4 Sep 2008, 10:07 am
This limitation applies to data derived from new clinical studies, reports of adverse events, and new analyses of previously submitted data, alike. [read post]
29 Jan 2020, 3:33 am
” According to DOJ’s press release: Practice Fusion Inc. [read post]
