New FDA website aims to save industries time and resources - KWWL - Eastern Iowa Breaking News, Weather, Closings

New FDA website aims to save industries time and resources


WATERLOO (KWWL) -- The U.S. Food and Drug Administration has a new web resource called FDA Basics for Industry.  The site is designed to help companies 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," said FDA Commissioner Dr. Margaret Hamburg. "In order to succeed, the FDA must clearly communicate standards and expectations to the industries it regulates."

The FDA says this site is one of 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.

FDA 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.

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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