New: FDA Import Requirements and Best Practices

January 12, 2016

AAEI is offering free downloads of its recent update to the manual, FDA Import Requirements and Best Practices for Drugs and Medical Devices.

A cross-functional team from branded and generic pharmaceutical and medical device companies prepared this manual in order to assist the US importer of FDA regulated merchandise. Compliance to the FDA’s import regulations and processes continues to be a core competency for U.S. importers as supply chains expand and become more complex. This manual should be utilized as one of many tools in an importer’s tool box for compliance with U.S. Participating Government Agencies with import jurisdiction.

This manual serves as a reference source and not meant to provide any legal or regulatory advice. Please note that the abbreviation FD&C Act refers to the Food, Drug & Cosmetic Act.

To download this publication for free, please click here.

A printed version is available, for a fee to cover the printing costs, by clicking here.