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Translating TMFs for Global Clinical Trials

Translating TMFs for Global Clinical Trials

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...
FDA Places Interim Process to Communicate Issues Found During Record Reviews

FDA Places Interim Process to Communicate Issues Found During Record Reviews

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...
AstraZeneca Unlikely to Receive EUA Approval Until April

AstraZeneca Unlikely to Receive EUA Approval Until April

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...
Injection for Treatment of Hereditary Angioedema Released in China

Injection for Treatment of Hereditary Angioedema Released in China

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...
Phase 3 Trial of Johnson & Johnson COVID-19 Vaccine Underway in Spain

Phase 3 Trial of Johnson & Johnson COVID-19 Vaccine Underway in Spain

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...
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