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L E G I S L A T I O N , R E G U L A T I O N S & S T A N D A R D S - FDA Issues Guidance On “Potassium Chloride Salt” - The U.S. Food and Drug Administration (FDA) has issued draft guidance for industry on the use of...more
Federal Circuit Interprets Statutory Requirements for Biosimilar Regulatory Pathway - Amgen Inc., v. Sandoz Inc., (Fed. Cir. July 21, 2015): In a case of first impression, the U.S. Court of Appeals for the Federal...more