Health Canada approves Biocon and Mylan’s trastuzumab biosimilar ‘Ogivri’ for HER2-positive cancers
Biocon and Mylan have received the clearance from Health Canada for the latter’s biosimilar Herceptin: trastuzumab co-developed under the brand name Ogivri... Read More
What is an “audit trail”?
Audit trail means a secure, computer-generated, time-stamped electronic record that allows for reconstruction of the course of events relating to the creation,... Read More
What is difference between New Drug Application and Marketing Authorization Application?
Process of reviewing and assessing the dossier to support a medicinal product in view of its marketing (also called licensing, registration, approval,... Read More