Personalized Medicine

FDA Regulation of Laboratory Developed Tests: Benefit or Unnecessary Burden?

by Antoinette F. Konski | Foley & Lardner LLP on 2/25/2013

The U.S. Department of Food and Drug Administration (“FDA”) has previously announced an interest in regulating diagnostic tests used in providing personalized medicine clinical care. Interested stakeholders such as the...more

FDA FY2012 Drug Approvals Equal FY2011 Mark

by Donald Zuhn | McDonnell Boehnen Hulbert & Berghoff LLP on 1/23/2013

Last month, the U.S. Food and Drug Administration released its annual report on innovative drug approvals, noting that the agency approved 35 novel medicines in FY 2012. The 35 approvals equaled the number of approvals for...more

Personalized Medicine Patenting Update

by Antoinette F. Konski | Foley & Lardner LLP on 1/14/2013

Patenting diagnostic methods is more challenging in the wake of the U.S. Supreme Courts Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. __ (2012) (Prometheus) and the USPTO’s application of the...more

Getting the Best Medical Care: a Newsletter from Patrick Malone - January 2013

by Patrick Malone & Associates P.C. | DC Injury... on 1/11/2013

In This Issue: - Six Things to Think About as Technology Advances - For More Information - Recent Health Care News You Should Know About - Check Out Our Previous Tips - Deep Thoughts for the New Year: Ethical...more

Funding Said Top Medical Research Area In 2013; Common Rule, COI Also Make List

by Carol Pratt, Ph.D. | K&L Gates LLP on 1/7/2013

Originally published in Medical Research Law & Policy Report, 12 MRLR 4, 01/02/2013. Regardless of what happens with the fiscal cliff negotiations in Congress and the Obama administration, research funding will...more

Personalized Medicine: An Industry Report

by Antoinette F. Konski | Foley & Lardner LLP on 12/31/2012

Increasingly, the development of new pharmaceuticals utilize genetic information to stratify patient subpopulations and/or predict efficacy and adverse events – the development paradigm of personalized medicine....more

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