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U.S. Department of Health and Human Services

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Letter From Task Force Chair, Transparency to Regulated Industry Report

January 2011

In response to President Obama’s commitment to openness in government and the U.S. Department of Health and Human Services making transparency a priority, FDA Commissioner Dr. Margaret Hamburg launched FDA’s Transparency Initiative in June 2009.  Since that time, FDA has created a new webpage, FDA Basics, with questions, answers, and videos for the public that has been viewed by more than 900,000 people, established an online program performance program, FDA-TRACK, with monthly metrics on more than 100 FDA offices, and proposed for discussion a series of steps to provide more public understanding of FDA decision-making and promote innovation.

Today marks the next milestone in the transparency process at the Agency.  The Task Force is releasing its report on transparency to regulated industry.  From our first public comment period in 2009, we have heard from small and large companies about the need for FDA to more clearly communicate about its standards and expectations—both for regulated products generally and for specific applications.  Clarity and consistency are pillars of an effective regulatory system that efficiently regulates products essential to health.

This report describes 19 steps FDA is taking to improve its transparency to regulated industry.  One of these steps—a new website called FDA Basics for Industry launches today.  Our goal is for this site to save many companies time and resources in understanding how to work with the agency.  We encourage feedback and are committed to making this site as helpful as possible.

In addition, FDA is setting the expectation of responding to email questions about the regulatory process within 5 days, whenever practicable, or acknowledge receipt of the question and provide an estimated time for response.  FDA is also making agency presentations at key meetings widely available and taking a range of other steps to improve transparency to manufacturers and the importing community.

FDA is proposing for comment five additional steps, including publishing on FDA-TRACK a timeline for high priority guidances that includes dates for publication of the draft guidance, receipt of public comments, and publication of the final guidance.  The Agency recognizes the importance of clarity about the regulatory process, and we are interested in comments on these proposed approaches.

We look forward to your continued engagement in the agency’s transparency efforts.

sharfstein signature

Joshua M. Sharfstein, M.D.
Principal Deputy Commissioner, Chair of the Transparency Task Force