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FDA Launches Website To Help Regulated Industries Save Time, Resources
Date:1/6/2011

ctations – both for regulated products generally and for specific applications," said Principal Deputy Commissioner Joshua Sharfstein, M.D., chairman of the agency's Transparency Task Force.

The report also contains five draft proposals to improve FDA's transparency to regulated industry. The draft proposals, available for public comment for 60 days, include publishing a timeline on the FDA website for high priority guidance documents in development. The FDA would disclose dates for publication of the draft guidance, receipt of public comments, and publication of the final guidance.

Commissioner Hamburg launched the FDA's Transparency Initiative in June 2009 in response to President Obama's commitment to openness in government and steps taken by the U.S. Department of Health and Human Services to make transparency a priority.

Since that time, the FDA has created a new Web page titled FDA Basics that features questions, answers, videos, and other materials describing how the FDA works to protect and promote public health. The page has been viewed by more than 900,000 people worldwide.

The agency also has established an online performance program for FDA offices nationwide. Called FDA-TRACK, the program features monthly metrics for more than 100 agency offices and provides insight for the public into the FDA's decision-making and regulatory activities.

For more information:

FDA Basics for Industry

http://www.fda.gov/FDABasicsforIndustry

FDA Transparency Initiative: Improving Transparency to Regulated Industry – Report

http://www.fda.gov/AboutFDA/Transparency/TransparencytoRegulatedIndustry/PhaseIIITransparencyReport/default.htm

FDA Transparency Initiative: Improving Transparency to Regulated Industry –
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SOURCE U.S. Food and Drug Administration
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