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Tick Tock re Tik Tok and FDA’s OPDP

Eye on FDA

The emergence of pharma on TikTok signals another facet in the evolution of healthcare communications and a similar pattern. Communicators and marketers would love black and white answers about concrete platforms. And they believe that the principles laid out to date cover pretty much any communications platform.

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From GRP to SIUU – the Evolution of FDA Guidance on Off-Label Dissemination of Scientific Information

FDA Law Blog: Biosimilars

By Dara Katcher Levy — Yesterday, FDA published a new Draft Guidance, “ Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers ” (SIUU Guidance or Draft Guidance).

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OPDP Outlines New Research

Eye on FDA

OPDP engages in a fair amount of formal study related to various aspects of its mission to protect public health by ensuring that prescription drug promotion is truthful, balanced, and accurately communicated. That is particularly true given that the 2009 framework has only been partially addressed by the agency.

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OPDP Issues First Regulatory Action Letter of 2022

Eye on FDA

Therefore, the agency said, the indication was not adequately communicated. FDA noted that the product has a boxed warning and that there have been past advisory communications from FDA have expressed concerns. It includes 352 letters covering over 450 communications vehicles and over 1100 violations.

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Health Innovators – Jo Brewer, Adaptimmune

pharmaphorum

Prior to this, he founded pharmaphorum in 2009, which was acquired by Healthware Group in June 2020.

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FDA OPDP Look Back at 2021 – The Yawning Gap

Eye on FDA

As noted in the past, there are two primary means for understanding the agency’s latest thinking with respect to promotional communications from pharmaceutical companies – the content and pattern of enforcement and the issuance of guidance documents to shed light on the parameters that exist.

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Health Innovators: Fredrik Debong, Hi.Health

pharmaphorum

Prior to this, he founded pharmaphorum in 2009, which was acquired by Healthware Group in June 2020.