Many years have passed since FDA began attempting to enunciate a regulatory approach to digital and social media – beginning in 2009 and still presumably on-going. In June the most substantive guidance yet was released by the agency addressing two critical areas that were outstanding – the correction of misinformation by third parties about prescription products and medical devices, and addressing the challenges of including risk information in product specific communications where there are character limitations.
With the passage of so much time, however, and since digital and social media are expansive topics, it is somewhat difficult to keep track of everything that has occurred. To help in that regard, I’ve put together a tab on the Eye on FDA blog site that contains the following:
Compilation of all relevant guidancesLinks to relevant Warning and Untitled LettersA link to my White Paper on the Regulation of Digital Media by FDA which compares enforcement patterns by OPDP for digital and non-digital communications vehicles;Links to relevant pages on the FDA site that pertain to the regulation of digital media
If there are any other resources on the FDA site that I have overlooked, by all means I welcome suggestions. In the meantime, I hope you will find this a useful resource.
Also, if you haven’t done so yet, there is still time to sign up for my free Webinar being given this Thursday, July 17 at 12 Noon E.S.T. – “In More than 140 Characters – FDA’s Social Media Guidance: Past, Present and Future” where I will be taking a comprehensive look at FDA’s approach to regulating social media by examining each of the five questions raised in the November 2009 hearing held on the topic.
Recent Warning Letters Mondaq News Alerts (registration) According to its website, the Office of Prescription Drug Promotion ("OPDP") has issued no warning letters in the last 60 days. Click here for a complete listing of 2014 OPDP Warning Letters.
The three enforcement letters sent by the FDA's Office of Prescription Drug Promotion (OPDP) to drug companies this year all address omission of risk information, according to an article posted on the Coalition for Healthcare Communication's website.
Using comparative claims in drug advertisements can make them more effective at persuading consumers that a drug is safer and more effective than the drug it’s being compared to, according to new research conducted by the US Food and Drug...
In its latest study of direct-to-consumer ads, the FDA wants to know if the inclusion of efficacy information in drug advertisements affects how patients perceive the drug. For the two-part study announced Monday ...
For the first time in nearly three months, the US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) has released a new Untitled Letter, this time alleging that a (RT @AlecGaffney: After Quiet Quarter, OPDP Releases ...
FDA seeks comments on proposed comparative price information study Lexology (registration) The FDA's Office of Prescription Drug Promotion (OPDP) will investigate the impact of price comparison information to better understand how the information...
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