Investigational New Drug

PhRMA’s new principles on conducting clinical trials take effect

PhRMA’s new principles on conducting clinical trials take effect

By Zachary Brennan

Last week, a new chapter of PhRMA’s Principles on the Conduct of Clinical Trials and Communication of Clinical Trial Results went into effect, detailing efforts to raise awareness around expanded access programs, which provide investigational drugs for...

CFDA accepts WuXi-MedImmune’s IND for new mAb

CFDA accepts WuXi-MedImmune’s IND for new mAb

By Zachary Brennan

The China Food and Drug Administration (CFDA) has accepted for review an Investigational New Drug (IND) application for WuXi and MedImmune's novel anti-IL6 monoclonal antibody (mAb) for rheumatoid arthritis. 

The warning letter comes as Cetero’s checkered past continues to come to light.

Former Cetero researcher hit with US FDA warning letter

By Zachary Brennan

A researcher with the now dissolved CRO Cetero Research received a warning letter released Tuesday from the US FDA after inspectors found that he, among other things, failed to ensure that the investigation was conducted according to plan.

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