April 11, 2012
Dear International Colleague:
I am writing to inform you that the U.S. Food and Drug Administration's (FDA) Office of International Programs (OIP) is making available FDA publications translated into various languages to enable our foreign counterparts and industry to better understand FDA’s laws and practices.
In June 2011, we announced the launch of FDA’s special report, Pathway to Global Product Safety and Quality. The report identifies the rapid changes regulators face due to globalization and discusses FDA’s efforts to develop an international operating model to ensure global product safety and quality. OIP appreciates the vital role our foreign counterparts play in helping the Agency build and strengthen the product safety net worldwide.
OIP is committed to supporting the Agency’s efforts to become a regulatory agency with a truly global reach. To this end, we are making FDA publications available in Arabic, Chinese, French, Portuguese, and Spanish to serve a broad international audience. These translations are accessible at www.FDA.gov/translations.
Translated FDA publications cover a cross section of product categories, including regulatory drug guidances, food guidelines (including food and dietary supplements labeling), medical device guidelines, and field inspection/ investigation manuals. You will also be able to access a central OIP Translation Inventory database, which can be sorted by product type or language to serve as a quick and easy reference tool to determine what FDA documents are available in which languages.
In the coming months, additional translated publications will become available. We hope that you will find this information useful and share it with industry and other organizations that would benefit from it. Should you have any questions or wish to provide user feedback, please contact OIPweb@fda.hhs.gov .
Mary Lou Valdez, MSM
Associate Commissioner for International Programs