Articles

Results 6 to 10 of 11


FDA Final Guidance on the Nonproprietary Naming of Biological Products: Update

USA - March 19 2019 On March 7, 2019, FDA issued draft guidance that describes FDA’s current thinking on nonproprietary names of biological products licensed under…

FDA Final Guidance on Immunogenicity Testing of Therapeutic Protein Products

USA - January 29 2019 On January 23, 2019, FDA issued final guidance on immunogenicity testing of therapeutic protein products. The guidance contains FDA’s nonbinding…

Error 101: IP Associations Propose Legislation for Patentable Subject Matter

USA - December 6 2018 Three prominent IP groups propose amending § 101 to clarify what is patentable subject matter. The American Bar Association (ABA) IP Section, and the…

Adriana L. Burgy

Error 101: Director Iancu Wants to Clarify Patentable Subject Matter

USA - October 25 2018 On September 24, 2018, USPTO Director Andrei Iancu told the Intellectual Property Owners Association (IPO) that examiners, applicants, patent owners…

Adriana L. Burgy

FDA Draft Guidance on Contents of a Complete Submission for Threshold Analyses and Human Factors Submissions to Drug and Biologic Applications

USA - October 8 2018 On September 28, 2018, FDA issued draft guidance on contents of a complete submission for threshold analyses and human factors (HF) submissions to…