US FDA Reprimands Arog Pharmaceuticals For Promo Of Investigational AML Drug
Third enforcement letter of the year cites meeting exhibit and webpage that suggest crenolanib is safe and effective for an unapproved use.
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US FDA Actions On Rx Drug Promos Covered New Territory Last Year
Office of Prescription Drug Promotion issued just six letters citing companies for improper drug promotion in 2020, including the placement of safety information in an email and making unfounded COVID-19 claims. New research projects focus on celebrity endorsements, medical conference materials.
Ascend’s EstroGel Promotion Misrepresents Efficacy Compared To Other Products, US FDA Says
Professional sell sheet falsely suggests estradiol gel contains lowest effective dose of estrogen compared to other estrogen products, OPDP says in fourth “untitled” letter of 2018.
FDA Rx Drug Promotion Rules Extend To Online Interviews, Pfizer Learns
Agency objects to video interview in which Pfizer spokespeople fail to mention risks of estradiol vaginal ring, in OPDP's second enforcement letter of the year.