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Veracuity Blog

Will pharmacogenomic testing become a routine part of clinical care?

Veracuity Blog Will pharmacogenomic testing become a routine part of clinical care? Some adverse drug events are a predictable consequence of therapeutic, especially dosing failures. Idiosyncratic toxicities, on the other hand, are much less predictable and much more insidious. Pharmacogenomics is a powerful tool that can reveal some of these vulnerabilities before toxicity occurs or, if performed after the fact, can explain the cause of an adverse drug event that has already happened. Clinical trials cannot detect all adverse drug events due to the limited population in which the drugs…

Utilizing pharmacogenomic testing to ensure effective therapy

Veracuity Blog Will pharmacogenomic testing become a routine part of clinical care? Some medications are administered as prodrugs that need to be metabolized in the active form by the body. An example of such a drug is codeine. It undergoes biotransformation into morphine by CYP2D6. Patients who transform codeine faster who are referred to as ultrarapid metabolizers, transform codeine into morphine so fast that they can develop opioid toxicity. On the other hand, poor metabolizers would not be able to produce enough active moiety, thereby making the drug ineffective. One…

Adverse incidents of medical devices

Veracuity Blog Adverse incidents of medical devices Medical Devices Regulation 2017/745 and In Vitro Diagnostic Medical Devices Regulation 2017/746 The new European legislation places numerous new obligations on manufacturers of medical devices marketed in Europe. The current requirements for reporting adverse incidents of medical devices in Europe are detailed in the Medical Devices Directive (MDD) [1], Active Implantable Medical Devices Directive (AIMD) [2] and In-Vitro Diagnostic Devices Directive (IVDD) [3]. The current procedures are described in Guidelines on a medical devices vigilance system [4]. The manufacturer is obliged to report…

Meeting reporting obligations for medical devices

Veracuity Blog Meeting reporting obligations for medical devices Medical Devices Regulation 2017/745 and In Vitro Diagnostic Medical Devices Regulation 2017/746 U.S. manufacturers of medical devices who are placing their devices on the European market have been facing many challenges relating to the new coming European legislation. The deadline for implementing the European Medical Devices Regulation (EU MDR 2017/745) and In Vitro Diagnostic Medical Devices Regulation (EU IVDR 2017/746) was postponed from May 2020 to May 2021 due to the COVID-19 outbreak, giving manufacturers more time to prepare. Manufacturers are required…