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Documents by Lawyers at this office
FDA Finalizes Three Guidance Documents on Biosimilars
Edgar J. Asebey,Maureen Bennett,Christian B. Fulda,Colleen Heisey,Christopher M. Mikson, May 15, 2015
FDA recently finalized three draft guidance documents addressing scientific and regulatory issues associated with the development and licensure of biosimilars.
EU Disclosure Requirements for Structured Finance Instruments
John Ahern,Neil J. Hamilton,Ulf Kreppel,Drew Salvest,Michelle Taylor, October 23, 2014
The European Commission has adopted a final regulation that sets out wide-ranging disclosure requirements for structured finance instruments ("SFIs") in circumstances where the issuer, originator or sponsor is established in the European Union ("EU").
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