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
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