Clinical service provider or CRO? Observations of FDA enforcement.
Last week, the FDA issued a warning letter after a study drug was administered even though the study had been placed on clinical hold.
EDC or CRO? Perceptions of data control.
From poor water quality to a hush-up of failing test results, we cover five warning letters the FDA sent to companies this week.
When is a CRO not a CRO? A look at 21 CFR Part 312.
November is right around the corner, and FDAzilla is starting it off right. We will be at the ISPE Annual Conference in Philadelphia! This post covers what at ISPE is particularly exciting for us at FDAzilla.
A challenge with interpreting 483s that are issued to firms other than your own is that 483s don’t provide the context for what occurred during the inspection and how the issues were identified. Thus, to evaluate the seriousness of a 483 and the potential for additional enforcement action, I ask the following questions.
We wanted to capture the wealth of experience we have in GCP Expert Jamie Colgin (or at least a bit of it). So we fired some questions and got some surprising answers.
Govzilla is on the road again! We hope to see you at the 27th Annual PDA/FDA Joint Regulatory Conference in Washington, DC from September 24th-26th. Here is the full list of speakers and events happening at the conference (including the one we wouldn’t miss).