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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...
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...
Newsletter for Leaders in the Medical Device Industry – November 2010 22 November 2010 Legal News: Medical Devices FDA and CMS Look Toward Parallel Approvals; Public Comments Accepted Until December 16, 2010 By Judith A. Waltz (jwaltz@foley.com) Although both the FDA...
Newsletter for Leaders in the Medical Device Industry – August 2010 02 August 2010 Legal News: Medical Devices Providing Reimbursement Advice Has Significant Risks for Manufacturers By Judith A. Waltz (jwaltz@foley.com) As part of product support, many device manufactures...
Newsletter for Leaders in the Medical Device Industry – March 2010 17 March 2010 Legal News: Medical Devices Regulatory Changes May Lead to More “Buy” and Less “Build” in the Medical Device Industry By Todd L. Boudreau (tboudreau@foley.com), Martin D. Mann (mmann@foley.com),...
Biosimilars Provision Included in House Health Care Reform Bill — The Time Has Finally Come 02 November 2009 Legal News Alert: Life Sciences On October 29, 2009, the Democratic leadership of the House of Representatives released the Affordable Health Care for America Act, H.R. 3962. The proposed legislation...
FDA Finalizes Rules on Access to Investigational Drugs 14 August 2009 Legal News Alert: Life Sciences On August 13, 2009, the U.S. Food and Drug Administration (FDA) published two final rules concerning access to investigational drugs and charging patients for investigational...
Medical Device Company Indicted for Off-Label Marketing and Statements Made to FDA During Regulatory Inquiry 19 June 2009 Legal News Alert: Life Sciences Medical device manufacturer Norian Corp. was indicted on June 16, 2009 for, among other things, several false statements the manufacturer’s personnel allegedly made...