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Documents by Lawyers at this office
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On August 28, 2015, the U.S. Food & Drug Administration ("FDA") released a draft guidance document describing its current position on biological product nonproprietary naming, including the need for biological products to bear a nonproprietary name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...
HHS Proposes Revisions to the Common Rule for Protection of Human Research Subjects
Edgar J. Asebey,Maureen Bennett,Michele R. Goodman,Glenn L. Krinsky,Heather O'Shea, September 10, 2015
On September 2, 2015, the U.S. Department of Health and Human Services ("HHS") and numerous other federal departments and agencies released the long-awaited proposed revisions to the Federal Policy for the Protection of Human Subjects, or "Common Rule," now published in the...