Janssen’s Spravato Clears Hurdles To Secure EU Approval
Written Interventions By Third Parties Had Earlier Raised Uncertainty
Executive Summary
Spravato has been approved for treatment-resistant depression in the EU notwithstanding last-minute objections by third parties.
You may also be interested in...
Blow For Janssen As England's NICE Rejects Depression Spray Spravato
Uncertainties over clinical and cost effectiveness are behind the health technology assessment body’s recommendation against Spravato's use on the National Health Service.
Last-Minute Pushback On Janssen’s EU Spravato Approval
What is in store for esketamine after third parties submit written interventions to the European Medicines Agency?
EU Consults On What Constitutes Personal & Commercially Confidential Data In Marketing Applications
Based on their experience with dealing with requests for access to documents over the past 12 years, EU regulators have proposed updating their guideline that provides for a harmonized approach to protecting personal data and business secrets in marketing authorization applications.