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IP Updates
Federal Circuit Speaks Regarding State Law Remedy for BPCIA’s “Patent Dance”
December 18, 2017
IP Updates
Summary of FDA Guidance on Determining Whether to Submit an ANDA or a 505(b)(2) Application
October 24, 2017
IP Updates
Summary of FDA Guidance on Statistical Approaches to Evaluate Analytical Similarity
October 5, 2017
IP Updates
Summary of Guidance on Interchangeability of Biosimilars With Reference Products
January 24, 2017
IP Updates
Summary of FDA Guidance on the Nonproprietary Naming of Biological Products
January 18, 2017
IP Updates
Summary of FDA Clinical Pharmacology Guidance for Demonstrating Biosimilarity
January 4, 2017