Many post-authorisation studies registered with the European Medicines Agency (EMA) fail to comply with legal requirements and recommendations to make their findings public, finds a study published by ...
The European Medicines Agency (EMA) on Friday announced it has published more than 1,000 post-authorization studies in a public online database. The database, referred to as the EU PAS Register ...
The European Medicines Agency (EMA) today issued draft scientific guidance intended to help sponsors design post-authorization efficacy studies (PAES). The guidance, which comes a year after a new ...