Results 1 to 5 of 14

FDA draft guidance addresses complexities in establishing active ingredient sameness in an ANDA

USA - December 7 2022 The U.S. Food and Drug Administration (FDA) recently published the draft guidance “Sameness Evaluations in an ANDA - Active Ingredients,” which aims…

Deborah Cho, Jason Conaty, Bryan Walsh

FDA finalizes guidance on Orphan Drug “sameness” of gene therapies

USA - October 1 2021 Recently, the U.S. Food and Drug Administration’s (FDA’s) Office of Orphan Product Development published the four-page final guidance “Interpreting…

Jason F. Conaty, George A. O'Brien, David M. Fox, Komal A. Karnik

New Orange & Purple Book laws increase transparency of patent information for drugs, biologics

USA - January 20 2021 On January 5, 2021, President Trump signed into law H.R. 1503, the "Orange Book Transparency Act of 2020," which amends provisions governing the types…

Jason F. Conaty, George A. O'Brien, David M. Fox, Jason A Leonard

Labeling carve-out does not shield generic drug makers from induced infringement claims, CAFC rules

USA - October 28 2020 The U.S. Court of Appeals for the Federal Circuit (CAFC) recently decided (2-1) in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc. that a…

Jason F. Conaty, David M. Fox, Jane Kalinina, Philip Katz

FDA to consider patent listing, therapeutic equivalence, and other Orange Book issues; agency will issue draft guidance documents, seek public comment

USA - February 4 2019 FDA Commissioner Scott Gottlieb, M.D. recently announced four steps FDA will be taking to ensure that the Orange Book (FDA’s publication of Approved…

Jason F. Conaty, George A. O'Brien