GCP Inspections: Corrective Measures For Adverse Findings Should Be Tested, US FDA Says
Sponsors, CROs and study investigators who receive an FDA Form 483 following a good clinical practice inspection should acknowledge the agency’s observations, explain the corrective actions planned, and how efficacy of those measures will be assessed, CDER officials say.
You may also be interested in...
Technological and logistical challenges have forced agency staff to triage document and interview requests to focus on the most important issues when conducting remote regulatory assessments and in-person inspections, an FDA official told a conference of international regulators.
The FDA’s concerns about conduct of ORIENT-11 trial include adequacy of informed consent, uncertainty about confidence in data generated in China, and failure of development partners Innovent and Eli Lilly to consult the US regulator about the study’s design.
Agency hints of a “hybrid” future of in-person inspections supplemented by alternative tools like remote interactive evaluations.