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U.S. Department of Health and Human Services

About FDA

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Reasoning: Action 1

FDA will develop a web-based resource called FDA Basics for Industry that will provide basic information online about the regulatory process governing FDA-regulated products, and include information that is frequently requested by industry.

Reasoning:

Ready access by industry to information online that sets forth FDA’s standards as well as expectations regarding regulated products may improve the efficiency of the regulatory process.  Less time will be spent searching for information; time that is better spent using this information to make more products that treat, diagnose, cure, and prevent disease available to the public.  In addition, more people would be able to access that information if provided online.

The Task Force concluded that developing an online resource that includes basic information about the regulatory process will make important regulatory information more broadly available to members of regulated industry.  In fact, the Task Force believes that this resource, which will be accessible to all members of industry, may in some cases meet the goal of wide dissemination of information more effectively than individual presentations by employees.

FDA Basics for Industry will serve as a portal to information that is frequently requested by industry.  This web-based resource will include links to training modules for industry, such as CDRH Learn and CDERLearn.  CBER is also developing an online training tool for industry, which is expected to launch in 2011.

The online resource for industry will be modeled on FDA’s successful efforts with FDA Basics, a web-based resource launched January 2010.  On FDA Basics, the public is provided with basic information about FDA and how the agency does its work.  FDA Basics includes over 155 questions and answers, nine short videos that explain various FDA activities and 14 interviews with FDA officials about the work of their offices.  The public is encouraged to rate the helpfulness of the content on the site and suggest additional questions to be added to the site.  Since its launch, over 40 questions have been added to the site based on feedback provided by the public. 

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