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www.fdanews.com/articles/158852-pharma-exempt-research-drugs-from-u-s-fda-border-processes

Pharma: Exempt Research Drugs From U.S. FDA Border Processes

September 23, 2013
Imports of drugs intended for research should be exempt from new U.S. Food and Drug Administration border processes implemented under the FDA Safety and Innovation Act (FDASIA), industry stakeholders say. Those that import such materials should not be required to submit additional information at the time of entry to demonstrate compliance with the 1938 FD&C Act, because to do so would be redundant, Pfizer writes in an Aug. 8 letter to the agency.
International Pharmaceutical Regulatory Monitor