US/EU Inspections MRA: Lessons Learned And Challenges Ahead for FDA
Executive Summary
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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 add two new products, including Ryzneuta, Evive Biotechnology's treatment for chemotherapy-induced neutropenia.