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US/EU Inspections MRA: Lessons Learned And Challenges Ahead for FDA

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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.

Ex-US FDA Official Sklamberg On Park Doctrine Limits, Data Integrity

Courts may increasingly find limits on how far Park Doctrine tool can be ‘pushed,’ Sklamberg says in wide-ranging interview with the Pink Sheet. Former US FDA deputy commissioner for global regulatory operations and policy, now with law firm Akin Gump, also shares his views on the US-EU MRA to recognize each other’s inspections and data integrity.

New EU Approvals

The Pink Sheet’s list of EU centralized approvals of new active substances has been updated to include a new product – Alnylam Pharmaceuticals' Givlaari for treating acute hepatic porphyria. The list, which contains information dating back to January 2018, includes brand name, generic name, company, therapeutic indication, date of marketing authorization and product type (eg, medicine, vaccine, biologic).

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