How Often Does FDA State Consultant Recommended in a Pharma WL?

William55401

Involved In Discussions
#1
Hello Cove. I have been active on this site responding to threads of interest for several years. However, this is my first time starting a thread. Background, I have med device experience but not so much on the drug side. I need help to understand.....

I am looking at an FDA Warning Letter (from Division of Pharma Q Operations) that lists the issues for a particular organization. Prior to the Warning Letter conclusion, FDA included language to the effect that FDA strongly recommends engaging a consultant qualified per 21 CFR 211.34 to assist. I have read 21 CFR 211.34 and understand the consultants must be qualified to perform the role. My question is, how often does this sort of recommendation, from FDA, occur in the drug world? Is this a normal practice? In my time in devices, I have never observed a recommendation like this in a Warning Letter. Thank you for your help in providing some perspective.
 
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chris1price

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#2
Hi, if you look through FDA Warning Letters, you will see this a lot for Pharmaceutical companies , to the point when I am surprised when I don't see it. However I don't know the rationale for when it is or isn't added; or why only pharma and not devices. Interestingly, the wording also changes between warning letters.
 
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