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OPDP Comes out Swinging With A Warning Letter on Unsubstantiated Efficacy

FDA Law Blog

And before CooperSurgical, another 2021 Warning Letter was issued to AcelRx for the infamous “Tongue and Done” tagline used to promote a Schedule II controlled substance subject to a REMS program that requires a healthcare professional’s precise placement of the drug using a single-dose applicator into the patient’s sublingual space.

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Analysis of primary care prescription trends in England during the COVID-19 pandemic compared against a predictive model

BMJ

We sought to analyse how prescribing trends have changed over time, utilising a dataset containing all prescriptions signed and dispensed in the UK by primary care facilities from January 2014 to November 2020. In addition, increased prescribing of a multitude of medications highlights groups particularly affected by the pandemic.