Announcement to the MAHs/applicants– Bio-analytical studies conducted at Cetero Research Houston, Texas

The US Food and Drug Administration (FDA) has raised some concerns following its inspection of Cetero Research facilities in Houston (Texas) about the conduct of bio-analytical studies in the period April 2005-June 2010.

The CMDh would like to identify all medicinal product dossiers, approved or pending approval, that include studies conducted at the above mentioned facility. MAH/applicants identifying studies conducted at this facility from April 2005 and onwards in any submitted dossier are asked to provide additional information. More details about the information to be provided are included in the letter from EMA to MAH/applicants that will be published on the CMDh website under “Advice from CMDh” (http://www.hma.eu/226.html).

Information should be sent via the established contact points at the AIFA (s.petraglia@aifa.gov.it) by 14th December 2011 at the latest.