Tag Archive: healthcare

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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Bart’s Corner: EU Regulatory Updates

EMA Working Programme for 2014 In December 2013, the EMA published its work program for 2014. It covered the many areas that the agency supervises and regulates. Much of the document is devoted to GMP, operational issues and other non-PV areas. But some comments in the PV sections are of[…]

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Exchange Plans’ Hidden Challenge: Co-Insurance

According to a recent report from the Department of Health and Human Services, over 8 million Americans enrolled to receive health insurance through the Affordable Care Act’s health insurance exchanges. The expansion of lives covered also comes with expanded benefits: preventive care, lab services, prescription benefits, and emergency services are[…]

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To Outsource or Not To Outsource? That May No Longer Be a Question

The healthcare landscape is changing dramatically… and many changes are yet to come. As such, outsourcing has increased in an effort to drive down cost and comply with the ever-changing regulatory environment.   Here are 4 outsourcing trends in the pharmaceutical and healthcare industries: Crisis Management Recall Support: During any[…]

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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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Outsourcing’s Increasing Role in the New Healthcare Model

It comes as no surprise to anyone that the healthcare landscape has changed dramatically in recent years and there is little doubt that many changes are yet to come; and when they do we’ll have to be agile and adapt once again. Due to recent changes, many companies are facing[…]

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Access and Reimbursement in the Post-ACA World

In Samuel Beckett’s tragi-comedy Waiting for Godot, Vladimir and Estragon spend their time anxiously awaiting the arrival of someone or something named Godot.  Godot in many ways, is like the Affordable Care Act: something that has been inferred and referenced to since its passage in 2010. Nearly four years out,[…]

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