Import of Human Drugs and Human Drug Components Webinar - June 16, 2011
The Food and Drug Administration, Center for Drug Evaluation and Research (CDER) Small Business Assistance Program is delighted to inform you of a unique opportunity for small business entities to learn more about the FDA and basic drug regulation. Our webinar series will highlight various aspects of drug regulation.
These focused webinars will support the Program’s mission of promoting productive interaction with regulated industry by assisting regulated domestic and international small pharmaceutical business with information relating to the development and regulation of human drug products.
On Thursday, June 16, 2011, we presented our webinar entitled Import of Human Drugs and Human Drug Components which focused on the compliance perspective of FDA’s import regulations on human drugs and human drug components. The discussion included topics such as detention, refusal of admission, Transportation and Exportation (T&E) and Foreign Trade Zones (FTZ).
This presentation was given by Bill Nychis, Senior Compliance Officer in the Import Operations Branch (IOB), Division of Import Operations and Recalls, Office of Drug Security, Integrity and Recalls, within the CDER Office of Compliance.
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