ORA Device Director: Inspection 'Program Alignment' Scheme Not Ready Anytime Soon; Investigator Training, Retention Pose Challenge For FDA
This article was originally published in The Gray Sheet
More details about FDA's new commodity-specific inspectional approach continue to emerge, including news that the Office of Regulatory Affairs is under pressure to train agency investigators while simultaneously dealing with the loss of several highly trained auditors to the agency's device center. All of this comes amid a sign-off process on "program alignment" that will extend all the way to Capitol Hill.
You may also be interested in...
Cures Bill Authorizes Inter-Center Institutes, But Will US FDA Create Them?
The agency is still working to get an oncology center of excellence off the ground and has other large pending reorganizations to tackle before it may get to creating additional centers intended to break down device, drug and biologic silos.
Cures Bill Authorizes 'Intercenter Institutes,' But Will US FDA Create Them?
Agency is still working to get oncology center of excellence off the ground and has other large pending reorganizations that could take precedence.
Pharma Blames EU IVD Regulation For Clinical Trial Delays
The challenges posed by the implementation of the EU IVD Regulation are having a negative impact on medicine trials using diagnostics. Many of such studies are currently stalled and research-based drug companies are calling on all partners to engage in dialog to find an urgent solution.