Tag Archive: FDA

Pharma’s Next Step: Tapping into Social Media to Support Critical Initiatives

Increase in social media adoption by both patients and physicians is beginning to catch the attention of market leaders within the pharmaceutical industry. While there is undoubtedly greater interest in utilizing social media capabilities, many pharmaceutical manufacturers are struggling to understand how social media activities support their core business goals.[…]

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Bart’s Corner: The Sentinel and Mini-Sentinel Initiatives

In 2008 in response to criticism and some safety issues and product withdrawals, FDA took a look at itself – with some outside help such as the FDA Amendments Act (FDAAA). This new law mandated the FDA to establish an active surveillance system for monitoring drugs using electronic data from[…]

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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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