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FDA’s Transparency Initiative Revealed at New Website

FDA Basics for Industry helps regulated industries save time and resources

Published: Thursday, January 13, 2011 - 14:53

(FDA: Silver Spring, MD) — The U.S. Food and Drug Administration (FDA) has introduced a new web resource called FDA Basics for Industry to help companies and others save time and resources in their interactions with the agency. The website includes basic information about the regulatory process, including information that is frequently requested by industry.

“Clarity and consistency are pillars of an effective regulatory system that efficiently regulates products essential to health,” says FDA Commissioner Dr. Margaret Hamburg. “In order to succeed, the FDA must clearly communicate standards and expectations to the industries it regulates.”

Part of the agency’s ongoing transparency initiative, the site is one of the 19 action items contained in a 46-page report, “FDA Transparency Initiative: Improving Transparency to Regulated Industry.” Other action items include:
• Setting an agencywide expectation that e-mail questions to the FDA involving the regulatory process will, whenever possible, receive an answer within five business days, or a response stating when an answer can be expected
• Making agency presentations at key meetings widely available
• Developing and executing a project to promote uniform processes and procedures across field districts

 

The entire list of action items contained in the report is available here.

“We have heard from small and large companies about the need for the FDA to more clearly communicate about its standards and expectations—both for regulated products generally and for specific applications,” says Principal Deputy Commissioner Dr. Joshua Sharfstein, 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 The FDA will disclose dates for publication of the draft guidance, receipt of public comments, and publication of the final guidance.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 the 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.

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The U.S. Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable, and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.