AnaMariaVR2
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Anulex sees layoffs after FDA warning letter
- Thread starter AnaMariaVR2
- Start date
Something about the article does not make sense to me.
The xompany rep states that they "consulted" with a number of IRBs and none of them "advised" him to go for an IDE.
From my perspective, one gets an IRB or IRBs to determine if the study is SR or NSR.
Informed consent of patients alone is not enough. The IRB is there to protect the public and ensure they are aware of the risks.
Alos this company promoted this "investigational" use on its website and then seems to have scrubbed this info.
Finally, not having any investigator agreements in place for some of the study sites along with everything else exhibits either gross incompetance or at least a cavilier attitude to the requirements for investigational studies and clinical affairs in general.
The fact that this is a surgical device manufacturer that has cleared products and the financial resources to institute compliant systems makes thier story even less credible in my mind.
I feel bad that folks were laid off and that a potentially helpful device is caught up in this mess, but for this chap to say that its extremely disruptive to his business is rish. Where was his executive responsible for clinicals?
The xompany rep states that they "consulted" with a number of IRBs and none of them "advised" him to go for an IDE.
From my perspective, one gets an IRB or IRBs to determine if the study is SR or NSR.
Informed consent of patients alone is not enough. The IRB is there to protect the public and ensure they are aware of the risks.
Alos this company promoted this "investigational" use on its website and then seems to have scrubbed this info.
Finally, not having any investigator agreements in place for some of the study sites along with everything else exhibits either gross incompetance or at least a cavilier attitude to the requirements for investigational studies and clinical affairs in general.
The fact that this is a surgical device manufacturer that has cleared products and the financial resources to institute compliant systems makes thier story even less credible in my mind.
I feel bad that folks were laid off and that a potentially helpful device is caught up in this mess, but for this chap to say that its extremely disruptive to his business is rish. Where was his executive responsible for clinicals?
M
MIREGMGR
Both of those are true, in my opinion, based on reading this guy's comments on how unreasonable the FDA is regarding the rules and their application.
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