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Critically, two of the efficacy studies were long-term investigations extending up to 24 weeks, providing meaningful data on sustained exposure safety

Four weeks is more conservative and preferred when running multiple cycles back to back

Additionally, we are finalizing our proposed edit to the regulation text at 42 CFR 416.174(c)(1) to remove the following text: which is determined to be zero dollars for calendar year 2025. We are removing this language pertaining to the portion of the otherwise applicable Medicare OPD fee schedule amount for CY 2025, as we will discuss the appropriate amount in each year's rulemaking

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Compounding and the FDA: Questions and answers