OPDP Comes out Swinging With A Warning Letter on Unsubstantiated Efficacy
FDA Law Blog
AUGUST 16, 2023
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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