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Prescribing Red Flags and Suspicious Controlled Substance Orders: Current Cautionary Tales

FDA Law Blog: Biosimilars

Unusual Amounts and Dosages Dispensing high doses of opioids in quantities far exceeding the daily morphine milligram equivalent (“MME”) dose recommended by the Centers for Disease Control and Prevention (“CDC”). The CDC has advised clinicians to carefully assess increasing total opioid dosage to greater than 50 MMEs per day).

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FDA’s Proposal to Remove Oral Phenylephrine from the OTC Monograph Isn’t a Surprise but What is Left “Over-the-Counter”?

FDA Law Blog: Biosimilars

Along with the proposed order, FDA issued as a supporting document the “ Scientific Review Supporting Proposed Administrative Order ” in which it describes the scientific data on the efficacy, pharmacology, and safety of oral PE underlying its determination to issue the proposed order.