Definitely yes to 2mg x 2 week dose given reduced dose request was based on an anomaly from historic study on a rat BUT no to removing adrenal monitoring despite follow-up studies that confirmed it wasn't linked to PPS.
FDA burnt too many times and given OA TAM potential they want to show extreme prudence.
Not a major deal rather impacts on patient convenience (takes extra time), their comfort and our cost.
2x2 Yay Or Nay From The FDA?, page-8
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