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FDA launches "Industry Basics" website

The US Food and Drug Administration has launched a new website designed to improve communication between the agency and industry

The US Food and Drug Administration (FDA) has launched a new website designed to improve communication between the agency and industry by making basic information about regulatory processes more accessible to companies in a user-friendly format.  The website is expected to help companies save time and resources in their interactions with the agency, the FDA said.

The new website includes sections on guidance; registration and listing; the product application and petition review process; and educational resources. Visitors to the site can also click a link to search the FDA's databases and can access a "popular content" section that includes various frequently used manuals and forms.

A "Frequently Asked Questions" section covers topics including drug review; drug approval; import and export; guidances; and drug registration.  By clicking on a "Stay Informed" link, users can sign up to receive email alerts from the FDA on topics of their choice.

The site can be accessed at www.fda.gov/ForIndustry/FDABasicsforIndustry.

The website is one of the 19 action items that are part of a recent 46-page report called "FDA Transparency Initiative: Improving Transparency to Regulated Industry." Other action items in the report include making agency presentations delivered at key meetings easily available on the internet and putting in place an "agency-wide expectation" that emails from companies containing questions about the regulatory process will be answered by the FDA within five days.

The initiative also includes a number of draft proposals related to making the workings of the FDA more transparent, including a proposal that the FDA will inform industry about the progress of high-priority guidances in development by disclosing a timeline from the start of the agency's work to publication of the final guidance. The draft proposals can be viewed in full on the FDA website and are open to public comment until March 6, 2011.

7th January 2011

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