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.
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ParaGard TV Spot Misrepresents Contraceptive’s Risks, US FDA Says
‘Untitled’ letter is FDA's third in the past eighteen months to target promotions for women’s health products. In the case of advertisement for CooperSurgical's copper-containing intrauterine device, which is regulated as a drug, the agency took issue with distracting visuals and reliance on superimposed text.
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.
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.