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Multinational Financial Groups After the U.S. Tax Reform: Selected Inbound and Outbound Issues

Introduction and Overview - The Tax Cuts and Jobs Act (“TCJA”) resulted in the most sweeping changes to the Internal Revenue Code (the “Code”) in decades and will result in countless articles and commentary to address the...more

FDA Issues Draft Guidance on Biosimilar Interchangeability

Agency outlines flexible, case-by-case approach to demonstrating interchangeability to reference products; emphasizes role of “switching studies” - On January 18, 2017, the US Food and Drug Administration (FDA or...more

Biological Products: New FDA Draft Guidance Sheds Light on Reference Product Exclusivity

Life sciences companies seeking protection for their biological products gain clarity on the submission procedures and standards of evaluation for reference product exclusivity requests. As the Food and Drug...more

The Regulation of Follow-on Biologics

What is new in the world of follow-on biologics? Manthei: Congress enacted the Biologics Price Competition and Innovation Act of 2009 to provide an alternative to the submission of a Biologics License Application for...more

Preparing for a "New Era of Medical Product Development"

FDA report demonstrates support for personalized medicine and more efficient regulatory pathways. In a new report issued by the Food and Drug Administration (FDA) on October 28, 2013, Commissioner of Food and Drugs...more

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