Friday, April 07, 2017 11:36:31 AM
The FDA does not publicly discuss drugs in the approval process (with the sole exception of the AdComs). They do not disclose holds, they do not disclose trials, they do not disclose anything.
The form 483 you mention would be to cite a manufacturing issue, not hold a trial (though the former could cause the latter).
Furthermore, they are not released to the public. They can be requested under the FOI act, and once such are pulled they may post it. I am not certain if they will pull one for an investigational drug though, as much of that is confidential per law.
AS far as being a stretch, yes. I really, really, really doubt that LP would allow the stock PPS to be destroyed when she could just point to an unrelated supplier they happened to use.
Besides which, why not just switch to some other? All we are talking is fairly normal blood test type stuff.
The form 483 you mention would be to cite a manufacturing issue, not hold a trial (though the former could cause the latter).
Furthermore, they are not released to the public. They can be requested under the FOI act, and once such are pulled they may post it. I am not certain if they will pull one for an investigational drug though, as much of that is confidential per law.
AS far as being a stretch, yes. I really, really, really doubt that LP would allow the stock PPS to be destroyed when she could just point to an unrelated supplier they happened to use.
Besides which, why not just switch to some other? All we are talking is fairly normal blood test type stuff.
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