Entry of Experimental Pharmaceutical Products and Investigational New Drugs

Importation of materials used to develop and test new pharmaceutical products (including investigational new drugs) is a highly specialized and technical process that is subject to multi-agency jurisdiction.

OFW’s attorneys are well-versed in the specialized requirements associated with entry of experimental pharmaceutical products and investigational new drugs, in pre-clinical trial, clinical trial, and post-clinical trial phases. We have provided guidance to numerous importers on duty savings that may be obtained through use of prototype entries and temporary importations under bond (“TIB”), as well as on valuation for CBP purposes of goods that are not yet for commercial sale. Cross-referencing the CBP issues with the deep experience of our colleagues in OFW’s FDA practice area ensures that all major regulatory requirements associated with these types of entries are covered by a unified team.