Feb 18, 2021 | Clinical Trials, e-Learning, Health, Pharmaceuticals, Regulatory
There is no doubt that clinical trials are vitally important in the drug development process. As an increasing number of clinical trials are conducted overseas, sometimes with multiple ongoing studies at once, having in-depth knowledge... 
Feb 3, 2021 | Clinical Trials, FDA, News, Regulatory
The U.S. Food and Drug Administration (FDA) has outlined an interim process for drug developers to relay any problems identified during record reviews instead of, or in advance of, preapproval inspections. Their responses will be taken into consideration before action... 
Dec 31, 2020 | News, Regulatory
According to Operation Warp Speed Chief, Moncef Slaoui, the AstraZeneca and Oxford University vaccine may not receive the U.S. Food and Drug Administration’s Emergency Use Approval (EUA) until April, despite the UK’s approval yesterday (12/30). Questions... 
Dec 8, 2020 | News, Regulatory
Today (12/8) Takeda announced the approval of the first modern preventative therapy for Hereditary Angioedema, TAHZYRO, for patients 12 and above from China’s National Medical Products Association (NMPA). The disease is chronic and life threatening, and it affects one... 
Nov 19, 2020 | News, Regulatory
The Agency for Medicines and Health Products, the Spanish health regulator, has just approved the trial of the second segment of Phase 3 for Johnson & Johnson COVID-19 vaccine in 9 hospitals across the country. The New Brunswick based...
