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
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
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
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
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