Apr 16, 2021 | News, Regulatory
The U.S. Food and Drug Administration’s (FDA) Advisory Committee on Immunization Practices (ACIP) met on April 14 to provide its recommendation regarding the pause of the Johnson & Johnson COVID-19 vaccine due to the association of extremely rare but...
Jan 21, 2021 | e-Labeling, EMA, Health, Language Service Provider, Medical Translation, Regulatory
On May 26th 2021, the European Union’s Medical Device Directive (MDD) (93/42/EEC) and Directive on Active Implantable Medical Devices (90/385/EEC) will be replaced and fully covered by the Medical Device Regulation (MDR). Since the original medical device directive’s...
Dec 10, 2020 | News, Regulatory
BioNTech released a statement on December 9, 2020 that Pfizer and their COVID-19 vaccine documents was “unlawfully accessed” in a breach on the European Medical Agency’s (EMA) system. The severity of the attack was not divulged, however the EMA disclosed that...
Nov 12, 2020 | News, Regulatory
Baxter Canada is increasing their product line in the realm of medication delivery and management with Novum IQ large volume syringe pumps, as they have just received marketing approval. The medical device uses new infusion protection...
