Tag Archive: FDA

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  In essence that’s what the FDA recently said in their draft guidance on “Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics.”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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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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Quality (QA QC QMS) Deficiencies

In May of this year I did a posting on the Quality Management Systems (QMS) that are obligatory for DS/PV departments based on FDA’s Quality Manual and the EMA’s Good PV Guidelines Module 1. Since then I have done many audits of drug safety and PV groups around the US[…]

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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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