It is the first treatment for type 1 diabetes prevention to receive approval. The US Food and Drug Administration (FDA) granted approval for the ground-breaking new medication Tzield on November 17, 2022. The combination of two medications in this injectable formulation may delay the onset of type 1 diabetes (T1D)...
After almost 25 years, the law on medical devices has changed. The “old” EU Directives (Medical Device Directive (MDD) 93/42 / EEC and Active Implantable Medical Devices Directive (AIMDD) 90/385 / EEC) were replaced by the Medical Device Regulation (MDR) 2017/475. European Union law considering medical devices has changed from...
What is considered burdensome or invasive? Where the investigation would involve submitting subjects to procedures additional to those performed under the normal conditions of use of the device and those additional procedures are invasive or burdensome, the Sponsor shall notify the Member States concerned at least 30 days prior to...
We are very happy and proud to be recognized as TOP 10 MEDICAL DEVICE CRO in Europe 2022. Successful clinical trial execution is built on the pillars of strategic planning, precise scheduling, and informed identification of countries and sites for trials. To meet these conditions, companies conducting clinical research...