Canada Implements New Recall/Disclosure Policy
This article was originally published in The Pink Sheet Daily
Executive Summary
Health Canada finalizes guideline on its new powers to order recalls or disclose information related to serious risks of injuries for drugs, but says it will develop more details on how it will use the authorities.
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New EU Approvals
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include five new products, including Lumoxiti, AstraZeneca's drug for hairy cell leukemia. The list, which contains information dating back to January 2018, comprises brand name, generic name, company, therapeutic indication, date of marketing authorization announcement and product type (eg, medicine, vaccine, biologic).
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