Registries supporting new drug applications

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Registries supporting new drug applications

PURPOSE Knowledge of the benefits and risks of new drugs is incomplete at the time of marketing approval. Registries offer the possibility for additional, post-approval, data collection. For all new drugs, which were approved in the European Union between 2007 and 2010, we reviewed the frequency, the type, and the reason for requiring a registry. METHODS The European Public Assessment Reports...

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ژورنال

عنوان ژورنال: Pharmacoepidemiology and Drug Safety

سال: 2017

ISSN: 1053-8569

DOI: 10.1002/pds.4332