Tag: drug safety

  • Off-Label Use & Safety

    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 implications for public health, patient…

  • Case Processing Deficiencies

    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 how to process individual case…

  • 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 of view.    Let’s take a…

  • 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 points. Routine PV and legalities…

  • 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 https://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 – probably early to mid 2014…