Submissions and Approvals

PhRMA Rejects GPhA’s Call for Same-Name Biosimilars

PhRMA placed itself in the middle of a mounting battle over biosimilar naming Monday, calling on the FDA to deny GPhA’s petition for same-name biosimilars and arguing that distinguishable, yet related names are “essential” for adverse event reporting. Read More

Health Canada Incorporates QbD In Updated Quality Guidance

Pharma companies applying for approval to sell drugs in Canada must submit quality summary documents, certifications of their products’ comparability with monographs of the European Pharmacopoeia and detailed drug master files that comply with the International Conference on Harmonisation’s (ICH) registration for human use quality standards. Read More