Tag Archive: FDA

FDA Webinar on Social Media Guidance

The FDA held a webinar last week regarding their recently-issued Social Media Guidance documents. Though many who registered were unable to access the webinar due to technical difficulties, the presentations slides and Q&A document were posted to the FDA website. In reviewing the slides, there were no major revelations presented[…]

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Data Monitoring Committees: Observations & Issues – Part II

In Part 1 of this post we started the review of some practical issues in the management and functioning of DMCs. We conclude here. Pushback I have seen situations where the sponsor uses the DMC only grudgingly and really does not want the DMC to act as an independent body[…]

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5 Best Practices for Pharma Social Media

The FDA’s most recent guidance has sparked lots of questions and conversations about how Pharmaceutical companies can effectively use social media. Given the regulatory challenges in social media, here are 5 best practices for pharmaceutical companies interested in using social media: Identify clear and specific objectives that lend themselves to[…]

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Data Monitoring Committees: Observations & Issues – Part I

Data Safety Management Boards (DSMBs), also known as Data Monitoring Committees (DMCs), are a complex issue. They are described in two similar documents, one from the FDA from 2006 and the other from the EMA. Another interesting document on these committees has been put out by the UK National Health[…]

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Public Health, Social Media and the Pharmaceutical Industry

2014 has become a blockbuster year for Social Media guidance from the FDA. This week the FDA published draft guidance on the “Do’s and Don’ts” of social media platforms with character limitations (like Twitter) and how to correct user generated content (UGC) with misinformation. In both of these publications, the[…]

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Excipients and Inactive Ingredients in Drugs & Drug Safety

In our world of drug safety and PV, we don’t think much about inactive ingredients and excipients found in drug products. In fact, we don’t even know which ones are in the drugs we take, make, sell and prescribe, and we may not even be sure where to find out[…]

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Drug Safety/ Pharmacovigilance & Social Media

Time to look again at the status of social media and its impact on drug safety. Unlike many other areas in life, the internet and social media have not yet played a major role in drug safety (DS) and pharmacovigilance (PV).  Although the internet and email are now playing a[…]

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Off-Label Use & Safety

There has been a lot of discussion regarding the off-label use of drugs.  This has been a focus of interest for FDA, EMA, MHRA and other health agencies around the world and certainly has been an issue and concern at companies over the years.  This is a complex issue with[…]

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Safety Items in the News

Several safety items have been in the news recently and are summarized here. Direct-To-Consumer Safety In February the FDA published a notice in the Federal Register (see: http://telerx.bz/4q) entitled: “Disclosure Regarding Additional Risks in Direct-to-Consumer (DTC) Prescription Drug Television Advertisements”.   The FDA is requesting comments within 60 days. This is[…]

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FDA Social Media Pharma Guidance

FDA Issues Social Media Guidance for Pharma

If you own “it,” finance “it” or influence “it” you are responsible for “it.”  In essence that’s what the FDA recently said in their draft guidance on “Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics.” Finally, the FDA has provided[…]

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