European Commission Gives Sneak Preview Of Hotly-Awaited Pediatrics Report
Executive Summary
The European Commission’s soon-to-be-published report on the EU Paediatric Regulation could lead to legislative changes that address some of the many problems pharma companies have with the 10-year old rules.
You may also be interested in...
EU Official Disappointed That Pediatric Development Still Seen As Just A 'Regulatory Requirement'
Weeks before an important report is due on the impact of the EU Paediatric Regulation, a senior European Commission official shares his personal reflections on how some simple concepts in the legislation have not translated into the real world as intended.
Tweeting The News: First Takes From EU Regulatory Conferences
The Pink Sheet’s London-based staff have been busy this week covering regulatory affairs conferences… and tweeting while they were there.
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.