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FDA Regulation of Laboratory Developed Tests: Benefit or Unnecessary Burden? 24 February 2013 Personalized Medicine Bulletin The U.S. Department of Food and Drug Administration (“FDA”) has previously announced an interest in regulating diagnostic tests used in providing personalized medicine...
FDA Issues Draft Guidance for Clinical Trials Using Enrichment Strategies 07 January 2013 Personalized Medicine Bulletin The Food and Drug Administration (FDA) recently issued a guidance document related to the conduct of clinical trials to support approval of human drugs and biological...
FDA and the Importance of Confidentiality 01 October 2012 BioPharm International Partner David Rosen authored an article that appeared in the October 2012 issue of BioPharm International titled "FDA and the Importance of Confidentiality." ...
Newsletter for Leaders in the Medical Device Industry – May 2012 May 2012 Legal News: Medical Devices Counting Down to Patent Reform: Steps That Medical Device Companies Can Take to Prepare By Courtenay C. Brinckerhoff (cbrinckerhoff@foley.com) Although President...
The Biologics Price Competition and Innovation Act: Implications for Implementation in Light of FDA Draft Guidance 16 February 2012 Legal News Alert: Life Sciences On February 9, 2012, after significant time had elapsed since the passage of the Biologics Price Competition and Innovation Act (BPCIA) of 2009, the FDA finally...
FDA Getting Tougher at the Border 14 December 2011 Pharmaceutical Compliance Monitor Foley Partner David Rosen authored an article that appeared in Pharmaceutical Compliance Monitor on December 14, 2011 titled "FDA Getting Tougher at the Border." ...
Trends In 'All Natural' Class Actions 10 November 2011 Privacy & Consumer Protection Law360 Foley Partners Michael Leffel and Nathan Beaver authored an article that appeared in Privacy & Consumer Protection Law360 November 10, 2011 titled "Trends In...
Newsletter for Leaders in the Medical Device Industry – October 2011 02 November 2011 Legal News: Medical Devices The New Patent Law: The Rules Have Changed, Your IP Strategies Must Also Change By Barry L. Grossman (bgrossman@foley.com) As of September 16, 2011, the rules...
Certifying To Medical Necessity Under FDA 21 April 2011 Health Law360 Foley Partners Lawrence Vernaglia and Nathan Beaver authored an article that appeared in Health Law360 on April 21, 2011 titled “Certifying To Medical Necessity...
Newsletter for Leaders in the Medical Device Industry – March 2011 24 March 2011 Legal News: Medical Devices Proposed Radio License Seeks to Advance Wireless Medical Device Innovation By Michael S. Kramer (mkramer@foley.com) The FCC has proposed a new experimental...