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19 Apr 2014, 8:50 am
Separately, note from footnote 163 of AN AGGREGATE APPROACH TO ANTITRUST: USING NEW DATA AND RULEMAKING TO PRESERVE DRUG COMPETITION, 109 Colum. [read post]
11 Apr 2014, 11:29 am
Hoffmann-La Roche, Inc. at *3.General Grounds for DissentHoffmann-LaRoche’s once-a-month Boniva® ibandro- nate medication for osteoporosis required twelve years of research and clinical testing and evaluation to demonstrate its efficacy when dosed once a month and its safety at this high monthly dosage. [read post]
31 Mar 2014, 6:06 am
Zeltiq Aesthetics, Inc. v. [read post]
16 Mar 2014, 6:07 pm
When carrying out these activities, most covered entities and business associates also will want to take steps to monitor potential responsibilities and exposures under other federal and state laws like the privacy and data security requirements that often apply to personal financial information, trade secrets or other sensitive data under applicable federal and state laws and judicial precedent. [read post]
14 Mar 2014, 12:00 pm
This wasn’t a case in which the ads were “in all practical respects indistinguishable from those of the for-profit clinics. [read post]
5 Mar 2014, 11:06 am
When carrying out these activities, most covered entities and business associates also will want to take steps to monitor potential responsibilities and exposures under other federal and state laws like the privacy and data security requirements that often apply to personal financial information, trade secrets or other sensitive data under applicable federal and state laws and judicial precedent. [read post]
1 Mar 2014, 12:51 pm
Caterpillar Logistics, Inc. v. [read post]
26 Feb 2014, 12:32 pm
Each facility's profile displays health and fire violations, performance in important clinical categories and how much time nursing staff spends with residents. [read post]
10 Feb 2014, 7:43 am
In re Ethicon, Inc., 2014 U.S. [read post]
9 Feb 2014, 6:18 am
Stanford and Stanford faculty-founded companies such as Stem Cells Inc, are blatantly promoted over others. [read post]
4 Jan 2014, 9:47 am
Selikoff had a general practice clinic in Paterson, New Jersey, in the 1950s, when his practice and his litigation support efforts were noticed by the asbestos insulation workers’ union. [read post]
3 Jan 2014, 5:52 am
Acuity Specialty Products Group, Inc., 664 F.Supp. 2d 137 (D. [read post]
26 Dec 2013, 9:49 pm
Stamer also regularly works with OCR, FTC, USSS, FBI and state and local law enforcement on privacy, data security, health care, benefits and insurance and other matters, publishes and speaks extensively on medical and other privacy and data security, health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. [read post]
19 Dec 2013, 6:12 am
FDA, ODE, “Summary Of Safety And Effectiveness Data (SSED) − Clinical Section Checklist,” at 6 (June 10, 2010) (emphasis added). [read post]
5 Dec 2013, 1:30 pm
Two companies — Wyndham Worldwide Corp. and LabMD Inc. [read post]
26 Nov 2013, 4:45 pm
The objective of the survey was to collect data to identify the current courses, faculty, programs, and research focus of IP educators in Canada. [read post]
4 Nov 2013, 9:56 pm
For example, when a J&J study of Risperdal showed a significant risk of strokes and other adverse events in elderly dementia patients, the complaint alleges that Janssen combined the study data with other studies to make it appear that there was a lower overall risk of adverse events. [read post]
4 Nov 2013, 9:08 am
Zimmer, Inc., 299 P.3d 463 (Okla. 2013), could be used to expand traditional tort causes of action under Oklahoma law in all sorts of novel and bizarre ways.Well, we still have that general concern, but if Clineis any indication, off-label use is not going to be one of those areas. [read post]
4 Nov 2013, 3:04 am
On November 4, the Department of Justice announced that Johnson & Johnson and its subsidiaries, Janssen Pharmaceuticals, Inc., and Scios, Inc., had agreed to pay $2.2 billion to resolve claims originally brought by whistleblowers that the company promoted its drugs Risperdal, Invega, and Natrecor for unapproved (off-label) uses. [read post]
22 Oct 2013, 11:54 am
Ethicon Endo-Surgery, Inc., 2013 WL 5556147 (Mag. [read post]
