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Documents by Lawyers at this office
The Data Retention Saga Continues: European Court of Justice and EU Member States Scrutinize National Data Retention Laws
Paloma Bru,Laurent De Muyter,Jonathon Little,Mauricio F. Paez,Undine von Diemar, August 23, 2016
Triggering a landslide of legislative reforms and legal battles, the European Court of Justice’s (“ECJ”) landmark judgment of April 8, 2014, Digital Rights Ireland (C-293/12), invalidated the Data Retention Directive 2006/24/EC, which provided that providers of publicly available...
FDA Proposes Regulatory Framework for Next Generation Sequencing-Based Tests
Edgar Asebey,Maureen Bennett,Christian B. Fulda,Colleen M. Heisey,Cristiana Spontoni, August 11, 2016
FDA recently released, as a part of President Obama's Precision Medicine Initiative, two draft guidance documents proposing what the Agency is calling a "flexible and streamlined approach" for regulating next generation sequencing ("NGS")-based tests. The first guidance...
FDA Takes Steps to Streamline Individual Patient Expanded Access
Edgar Asebey,Maureen Bennett,Christian B. Fulda,Colleen M. Heisey,Cristiana Spontoni, August 3, 2016
On June 2, 2016, FDA announced the availability of three final guidance documents aimed at simplifying and clarifying expanded access for investigational drugs and assisting health care professionals, patients, and industry in navigating the expanded access process. In the FDA blog, FDA Voice, Dr....
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