EMEA – FDA COOPERATION
November 1st, 2003
BY KEITH NUTHALL
THE EUROPEAN Agency for the Evaluation of Medicinal Products (EMEA) and the United States' Food and Drug Administration (FDA) have launched their first parallel scientific advice procedure since September's signing of a confidentiality agreement regarding such cooperation. This first pilot exchange of views follows a request from a (unnamed) pharmaceutical manufacturer for guidance on approving orphan medicinal products.
THE EUROPEAN Agency for the Evaluation of Medicinal Products (EMEA) and the United States' Food and Drug Administration (FDA) have launched their first parallel scientific advice procedure since September's signing of a confidentiality agreement regarding such cooperation. This first pilot exchange of views follows a request from a (unnamed) pharmaceutical manufacturer for guidance on approving orphan medicinal products.
Full access to this article can be arranged with permission from the client that first ordered it. Please contact us to request access. Entries are uploaded to our archive at least one year after being published by a client – free access is restricted to International News Services journalists for background research only. The article date indicates when copy was filed to a client, not when posted to this archive. Upon client requests, International News Services will remove such articles from the archive or not upload them in the first place. They are included to demonstrate the breadth of topics undertaken by the agency and also to help promote clients’ coverage.