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U.S. Department of Health and Human Services

International Programs

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Office of International Programs Frequently Asked Questions (FAQs)

1. Q: What is FDA’s Globalization Initiative?

A: Working globally helps the Food and Drug Administration (FDA) better accomplish its domestic mission to promote and protect the public health of the United States. The posting of FDA staff in certain overseas regions is a key part of the agency's strategy for expanding oversight of imported food and medical products. Areas in which FDA is establishing overseas posts include China, India, the Middle East, Europe, and Latin America...read more

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2. Q: Does the FDA foreign offices offer a way to increase the approval of applications?

A: No, the approval process is not expected to change. However, with in-country presence, it is hoped that regular communication between FDA representatives and foreign industry will increase knowledge regarding FDA standards and expectations, thereby positively affecting approvals.

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3. Q: How does FDA oversee domestic and foreign drug manufacturing?

A: All drugs approved in the United States, regardless of where they are made, must be in compliance with the Federal Food, Drug, and Cosmetic Act, which requires that drugs meet manufacturing standards to assure quality and product label requirements. FDA oversees domestic and foreign drug manufacturing in several ways...read more

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4. Q: What is FDA’s international role regarding cosmetics?

The Office of Cosmetics and Colors (OCAC) likewise have directed increasing efforts toward issues related to the international cosmetic market. Among the ways in which OCAC works with other regulatory agencies and the regulated industry to facilitate international trade are...read more

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5. Q: Where can I find more information on FDA Recalls?

A: When an FDA-regulated product is either defective or potentially harmful, recalling that product—removing it from the market or correcting the problem—is the most effective means for protecting the public.

Recalls are almost always voluntary. Sometimes a company discovers a problem and recalls a product on its own. Other times a company recalls a product after FDA raises concerns. Only in rare cases will FDA request a recall. But in every case, FDA's role is to oversee a company's strategy and assess the adequacy of the recall.

http://www.fda.gov/Safety/Recalls/default.htm
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm049070.htm

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6. Q: How do I contact FDA?

A: Need Information About the Registration of Food Facilities or Registration of food facilities help desk Phone: 800-216-7331 or 301-575-0156 or do you have a comment/question about the Website? We'd like to hear from you. If you wish you may contact FDA staff or offices by mail or telephone find out how...read more

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7. Q. How do I contact FDA’s Foreign Offices?

A. The U.S. Food and Drug Administration’s (FDA) Office of International Programs (OIP) is the focal point for the agency’s international efforts. Working with representatives of the various program components, the mission of the agency is accomplished in collaboration with international health and regulatory partners through ongoing communications, both emergency and ad hoc, cooperation on health and regulatory issues, exchanges of public and non-public information and documents, technical cooperation and training, personnel exchanges, and certification of certain products exported to and from the United States.

The Federal Food, Drug and Cosmetic Act mandates, as part of FDA’s statutory mission, collaboration with foreign regulatory authorities to reduce regulatory burdens, harmonize regulatory requirements, and establish appropriate reciprocal arrangements. FDA’s international work has grown exponentially over the past decade, as we respond and adapt to a global society. To learn about FDA’s foreign posts...read more

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8. Q. Where can I find information about the FDA Transparency Initiative?

In June 2009, Food and Drug Administration (FDA) Commissioner Dr. Margaret Hamburg launched FDA's Transparency Initiative and formed an internal task force to develop recommendations for making useful and understandable information about FDA activities and decision-making more readily available to the public, in a timely manner and in a user-friendly format...read more

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9. Q. Where can I find information on FDA’s International Arrangements and a list of participating countries?

FDA’s mission includes the mandate to, “Participate through appropriate processes with representatives of other countries to reduce the burden of regulation, harmonize regulatory requirements, and achieve appropriate reciprocal arrangements.” In pursuit of appropriate international collaborations, FDA utilizes a wide variety of International Arrangements, such as:

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10.Q. Where are FDA’s foreign posts and where are they located on the web?

A. To learn more about FDA's foreign posts, please select the link below.