Drug Approval and Patent Listing Process -
Before being allowed to market a new drug1 in the U.S., branded drug manufacturers must submit a new drug application (NDA) to the U.S. Food and Drug Administration (FDA), and...more
On November 11, 2013, the U.S. District Court for the Northern District of California in Sandoz, Inc. v. Amgen, Inc. and Hoffman-La Roche, Inc., Docket No. C-13-2904, made the first-ever judicial interpretation of the...more