Clinical Trials in the USA
The US FDA requires that a drug be the subject of an approved marketing application before it is transported or distributed across the US-state lines. This Application is known as an Investigational New Drug (IND). The IND is the means through which the sponsor technically obtains this exemption from the FDA.
USA clinical trial guidances are coming soon!
GRP Video: IND Registration in USA
GRP Video on IND registration in the USA, explains how to Perform a gap analysis ; Define the regulatory strategy for your IND application; Prepare and Compile your IND application and how to Publish and submit your IND application to FDA.
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