US/EU Inspections MRA: Lessons Learned And Challenges Ahead for FDA
Executive Summary
You may also be interested in...
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.
Outlook Turns To Marketing Strategy After Scoring EU First For Ophthalmic Bevacizumab
Outlook Therapeutics’ intravitreally injected Lytenava has won the thumbs up from the European Medicines Agency. The company is assessing both direct commercialization of the product and partnering in Europe on a country-by-country basis.