IRB Oversight: HHS’ Registration Practices, Firms Conduct To Face Greater Scrutiny
This article was originally published in The Pink Sheet Daily
Executive Summary
Hearing in House may boost prospects of legislation that would impose new requirements on the initial approval of clinical trials.
You may also be interested in...
Adverse Event Reporting: Sponsors, FDA Disagree On Responsibilities To IRBs
Drug developers are pushing back against FDA's effort to place on them the major responsibility for providing the information that the institutional review boards need for continuing reviews
Adverse Event Reporting: Sponsors, FDA Disagree On Responsibilities To IRBs
Drug developers are pushing back against FDA's effort to place on them the major responsibility for providing the information that the institutional review boards need for continuing reviews
Enrollment Suspended In Trials Approved By Coast IRB After FDA Warning Letter
Many large and small drug firms are clients of Coast IRB, which was caught approving a fraudulent study.