dan_philly said:If you are going to change something, change one thing and give it long enough to express itself.
Thank you for spelling out the reasoning rather than just the conclusion. Printing the relevant bit and taking it with me.
dan_philly said:If you are going to change something, change one thing and give it long enough to express itself.
Thank you for spelling out the reasoning rather than just the conclusion. Printing the relevant bit and taking it with me.
From the other side of the consultation, briefly. There is a difference between no evidence and evidence of no effect, and this subject is one where the two get swapped freely in both directions.
pete_nash said:There is a difference between no evidence and evidence of no effect, and this subject is one where the two get swapped freely in both directions.
Second this. Posting only so the count is not one.
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View Resultspete_nash said:There is a difference between no evidence and evidence of no effect, and this subject is one where the two get swapped freely in both directions.
Adding the part of the answer the thread has not reached. The shortage clause is the answer to the second question and it is a subtraction rather than an addition. Both exemptions forbid compounding something that is essentially a copy of a commercially available approved product. A product FDA has listed as in shortage is not treated as commercially available, so listing removed the objection that otherwise blocked compounding. It never created a permission; it withdrew a prohibition, which is why it evaporated the moment the supply fact changed.