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International Information Sharing is Impacting FDA Inspection and Enforcement Decision-Making

Sep 7th, 2011

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The deepening channels of international information sharing are having an increasing impact on inspection decision-making and activities at FDA.

Regulatory agencies are being more open with each other and sharing inspection results as a way to improve both agency efficiency and industry compliance.  Joint inspections, including initiatives between the US and Europe for finished products and the US, Europe and Australia for APIs, are also enhancing interagency linkages and increasing the comfort levels needed to share sensitive information.

The establishment of FDA offices in foreign countries is another manifestation of the deepening channels through which the inspection-related information sharing and decision making are flowing (IPQ “In the News” September 7 companion story).

At the DIA Annual Meeting in Chicago in June, CDER Office of Compliance Division of International Drug Quality Acting Director Carmelo Rosa provided recent examples of how FDA inspection processes are being affected by interagency cooperation.

Rosa’s examples illustrate the process and the outcomes of what the agency calls “desktop reviews” – using available information to help determine foreign inspection priorities.  The reviews now include consulting with other regulatory agencies and examining their reports as inputs to the decision-making process.  Rosa noted that his division performed 13 such reviews in 2009, 22 in 2010 and had expanded to 37 during the first six months of 2011.

[The story continues for subscribers beginning in page 2.  Nonsubscribers can purchase the full story along with the companion story on FDA foreign offices for $195 by contacting Wayne Rhodes ([email protected]).  For subscription/license information, click here.]

Also see related stories:

FDA Foreign Offices Making Progress in Helping Advance Agency Initiatives

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Lab Data Integrity at Issue in FDA Warning Letters Sent to China and India

FDA Micro Lab Data Concerns Continue with Warning Letter to Second Indian Firm

FDA/EMA Joint Inspection Program for Finished Products Seeking Applicants

International Joint API Inspection Pilot Program Sees Positive Results

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