EMA Pilot For Early Advice On Pediatric Research Finally Gets Going
This article was originally published in The Pink Sheet Daily
Executive Summary
EMA has gotten applications from sponsors for early advice on developing medicines for pediatric indications, under one-year pilot project.
You may also be interested in...
EMA To Improve Early Pediatric Advice Initiative
The European Medicines Agency is to fine tune its early interaction initiative to help companies shape their pediatric development plans alongside programs for adults.
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.
Global Pharma Guidance Tracker – March 2024
Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.