FDA Approves Four More Member States For US-EU Inspections MRA
The landmark mutual recognition agreement is now operational between 12 EU member states and the US Food and Drug Administration.
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As US FDA sets its FY 2018 inspection priorities, it is considering whether there are recent or upcoming inspections by inspectorates in eight European countries recognized under a US/EU mutual recognition agreement that it could rely on instead, agency official says. Over time, FDA could rely more on EU inspection priorities.
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).