Regulatory Affairs

Canada Finalizes GMP Rules for API Manufacturers

Active pharmaceutical ingredient (API) manufacturers operating in Canada must establish clearly defined and controlled manufacturing processes to ensure consistency under Health Canada’s newly finalized good manufacturing practices (GMP) guidelines. Read More

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