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11 Feb 2009, 1:55 pm
A REMS will be required if FDA finds that a REMS is necessary to ensure that the benefits of the drug or biological product outweigh the risks of the product, and FDA notifies the sponsor. [read post]
9 Feb 2009, 5:10 am
  However, if such claims are based solely on allegations that the respective defendants violated the FDCA, then the claims are preempted.The case involves a group of seven health benefit plans accusing Amgen, Inc., DaVita, Inc. and Fresenius Medical Care Holdings, Inc. of unlawfully promoting the off-label use of two drugs, Epogen and Aranesp (collectively, “EPO”), between 2002 and 2007. [read post]
29 Jan 2009, 5:00 am
The new BrightScope Rating™ debuted today (see Press Release) at the 2009 Los Angeles Benefits Conference, co-sponsored by the Internal Revenue Service (IRS), the American Society of Pension Professionals & Actuaries (ASPPA) and the National Institute of Pension Administrators (NIPA). [read post]
29 Jan 2009, 5:00 am
The new BrightScope Rating™ debuted today (see Press Release) at the 2009 Los Angeles Benefits Conference, co-sponsored by the Internal Revenue Service (IRS), the American Society of Pension Professionals & Actuaries (ASPPA) and the National Institute of Pension Administrators (NIPA). [read post]
24 Jan 2009, 12:38 pm
Rearden Commerce, Inc., 2009 WL 102075 (N.D. [read post]
22 Jan 2009, 2:00 am
Cargill, Inc., 395 F.3d 882 (8th Cir. 2005), held that the plan administrator’s refusal to allow the plaintiff to review and rebut the opinion of the plan’s independent medical examiner denied her a “full and fair review” of her claim. [read post]
22 Jan 2009, 2:00 am
Cargill, Inc., 395 F.3d 882 (8th Cir. 2005), held that the plan administrator’s refusal to allow the plaintiff to review and rebut the opinion of the plan’s independent medical examiner denied her a “full and fair review” of her claim. [read post]
4 Dec 2008, 12:10 pm
(ALJ Maier, U-27486, 3/11/08)PROFESSIONAL, CLERICAL, TECHNICAL EMPLOYEES ASSOCIATION AND BUFFALO CITY SCHOOL DISTRICT. [read post]
4 Dec 2008, 12:05 am
Signs WifiMed Holdings Company, Inc … Medicare says ‘no' to medical errors For Your Benefit Writing a Prescription for Safety: B. [read post]
3 Dec 2008, 4:54 pm
Matter remanded for consideration of issues raised but not determined ADMINISTRATIVE LAW, GOVERNMENT BENEFITS, LABOR & EMPLOYMENT LAW In the Matter of Gormley v. [read post]
31 Oct 2008, 3:34 pm
” [Pages 9-10 of letter from Solomon Sobel, MD, Center for Drug Evaluation and Research (CDER) Food and Drug Administration dated April 13, 1999]. [read post]
23 Oct 2008, 10:31 am
Because of that, it is important to understand their risks and benefits. [read post]
6 Jun 2008, 6:49 am
: (Spicy IP)   Events 9-12 June: (US) Strategies for management of IP – Chicago: (IPR-Helpdesk), 11 June: US PLI ‘Advanced patent licensing 2008: What you need to know before licensing your patent’ – San Francisco: (Patent Docs), 11 June: MARQUES ‘First meeting with Spanish Judges of the Community Trade Mark Courts’ – Alicante: (Class 46), 13-14 June: Centre for European Economic Research conference on ‘The… [read post]
30 May 2008, 1:39 pm
"We can't lose sight of the benefit of this product, the public health benefit is clear. [read post]
23 May 2008, 1:03 am
– Brdo: (IPR-Helpdesk), 5-6 June: USFDA public meeting on evaluation of product trade names: (FDA Law Blog), 9-12 June: (US) Strategies for management of IP – Chicago: (IPR-Helpdesk), 11 June: MARQUES ‘First meeting with Spanish Judges of the Community Trade Mark Courts’ – Alicante: (Class 46), 16 June / 1 July: US PLI: ‘Prior art & obviousness 2008: The PTO and CAFC perspective on patent law sections 102 & 103’ -… [read post]