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Documents by Lawyers at this office
FDA Holds Back-to-Back Workshops on Next-Generation Sequencing Diagnostic Tests
Edgar J. Asebey,Maureen Bennett,Christian B. Fulda,Colleen Heisey,Cristiana Spontoni, November 27, 2015
Last week, FDA held two workshops to gather information on developing a flexible approach for the regulation of next generation sequencing ("NGS") in vitro diagnostic tests. NGS tests facilitate the rapid sequencing and analysis of segments of DNA, yielding information that can be used to...
EU Court Suspends EMA Decision to Grant Access to Drug Data
Edgar J. Asebey,Maureen Bennett,Christian B. Fulda,Colleen Heisey,Cristiana Spontoni, September 24, 2015
On September 1, 2015, the European General Court granted an interim order in favor of Pari Pharma, temporarily suspending the operation of a decision by the European Medicines Agency ("EMA") to allow Novartis Europharm to gain access to reports on Pari Pharma's drug Vantobra under the...
FDA Indicates Shared Nonproprietary Names Not Appropriate for All Biological Products, Including Biosimilars
Edgar J. Asebey,Maureen Bennett,Colleen Heisey,Janet M. McNicholas,Christian Paul, September 11, 2015
On August 28, 2015, the U.S. Food & Drug Administration ("FDA") released a draft guidance document describing its current position on biological product nonproprietary naming, including the need for biological products to bear a nonproprietary name to which is attached an...