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As Pharma company’s continue to look for opportunities to accelerate, there have been questions raised about the opportunity to import CT materials to support milestones prior to having an IND “in-effect”. While there is language on the FDA IND acknowledgement letter that enables sponsor to ship to site, this language does not enable importation into the country for Drug Substance (DS) or Drug Product (DP) made outside of the United States.
It has long been the standing process at my company that we do not import for human-use drug substance into the US until the 30 day IND wait time is up. Lately, there’s been conversation bubbling up about risk acceptance to import with FDA acceptance letter vs 30d wait.
I would like to understand what your experience is with this 30 day wait time? What level of risk has your company been willing to accept, if they are importing, before the 30 days are up?