What are the PROLabels information sources?
We analyse the information disclosed by the US Food and Drug Administration and by the European Medicines Agency on their respective websites (http://www.fda.gov/cder and http://www.emea.eu.int ). Up to now, we have analysed European Public Assessment Reports (EPARs) reviewed by the EMA through the centralised procedure since 1995, New Molecular Entities (NMEs) approvals available from the FDA since 1998 and Biological Products (BLAs) approvals available from the FDA since 2004. In addition, we have undertaken a large development plan to include, from 2008 on, all New Drug and Biological Approvals (i.e. NMEs, BLAs, revisions, efficacy supplements) in the database as soon as they are published on the FDA website. We have also started a retroactive review from 2007 and working backwards.
