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

SILVER SPRING, Md., Jan. 6, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today introduced a new Web resource called FDA Basics for Industry (www.fda.gov/FDABasicsforIndustry) to help companies and others save time and resources in their interactions with the agency.

(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)

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," said FDA Commissioner Margaret Hamburg, M.D. "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 titled "FDA Transparency Initiative: Improving Transparency to Regulated Industry." Other action items include:

  • setting an agency-wide 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 expe
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SOURCE U.S. Food and Drug Administration
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