#15 on the FDA FAQ's talks about changes to the product formulation and says that such changes should not affect ODD (see below).
Now whether changes to a product formulation affects safety data, Ph2, I don't know. Perhaps though the same logic works, i.e. it is not considered a new drug by the FDA (assuming the active component is not changed).
Just some thoughts.
DYRO And all that
#15 on the FDA FAQ's talks about changes to the product...
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