Abstract: Post Authorization Safety Studies (PASS): Application of Prospective Observational Study Methodology

 

Abstract: Post Authorization Safety Studies (PASS): Application of Prospective Observational Study Methodology

A post authorization safety study (PASS) is a study of a marketed drug or biologic conducted in an effort to confirm the safety profile or identify potential safety issues not identified in the controlled clinical trial population. A PASS may be done voluntarily or in response to requirements imposed by an approving authority. According to the ENCePP website, there are 228 PASS protocols registered, of which 187 are currently in active recruiting or planning status.