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Reply To: IND "in-effect" US Importation – BenchmarkOctober 11, 2019 at 1:44 pm
I can say for our company we have been importing drug product into US based on availability of the FDA acceptance letter for the past 10+years. This is based on the verbiage included in acknowledgement letter “It has not been our policy to object to a sponsor, upon receipt of this acknowledgement letter,either obtaining supplies of the investigational drug or shipping it to investigators listed…”
FDA/Customs have not held any of our shipments if shipped prior to the 30 day wait time.