Tag Archive: Pharmacovigilance

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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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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Case Processing Deficiencies

In our last posting we discussed problems in quality management systems found during audits and inspections.  In this posting we want to discuss problems seen during inspections regarding the processing of individual case safety reports (ICSRs). Health agencies, in particular the FDA and the EMA/member states, have detailed requirements on[…]

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Risk

In drug safety, pharmacovigilance, drug development and many other areas that we are involved in there are extensive discussions and even more extensive documents written to evaluate benefits and risks.  Most of us don’t think too much about the concept of risk itself from a more theoretical and conceptual point[…]

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Generic Safety Labeling: FDA’s new regulation – Part 2

In Part 1 we looked at the old and the proposed new regulation on generic labeling.  Now we will take a look at possible implications. Comments and Implications The new regulation will change the landscape for all the stakeholders. Branded Companies For branded companies there will be good and bad[…]

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Generic Safety Labeling: FDA’s new regulation – Part 1

On November 8, 2013 FDA published an announcement in the Federal Register regarding new labeling requirements for generic drugs.  (See http://telerx.bz/3n) It was officially published November 13, 2013.  There will be a 60 day comment period and then, presumably, FDA will make the regulations final and they will take effect –[…]

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