Archive for January, 2011

FDA Posts First Annual Report Measuring FDA’s Success in Receiving Early Warning About Problems with Food and Animal Feed

January 27, 2011 21 comments

The Reportable Food Registry (RFR or Registry) is an electronic portal for industry to report when there is a reasonable probability that an article of food will cause serious adverse health consequences.  The Registry helps the FDA better protect public health by tracking patterns and targeting inspections.  The Food and Drug Administration Amendments ACt of 2007 directed FDA to establish a Reportable Food Registry for industry.  The Registry applies to all FDA-regulated categories of food and animal feed (including pet food).  Dietary supplements and infant formula are not included.

FDA has posted on the FDA Web site the first annual report that measures the agency’s success in receiving early warning about problems about human food and animal feed.  The report, entitled “The Reportable Food Registry: A New Approach to Targeting Inspection Resources and Identifying Patterns of Adulteration,” includes information about the number and types of reports submitted to the Registry, as well as FDA initiatives launched in response to information from the Registry. 

Afia Asamoah, Transparency Initiative Coordinator

Materials Available from FDA Basics Webinar on the FDA’s Center for Tobacco Products State Enforcement Program

January 19, 2011 10 comments

Did you miss the FDA Basics webinar about FDA’s Center for Tobacco Products State Enforcement Program?  FDA is contracting with states and U.S. Territories to help with compliance and enforcement activities in order to limit the availablity of tobacco products to young people.

Materials from the webinar are now available on the FDA Basics website.

Check out the “What’s New” tab on the FDA Basics homepage to download materials from the webinar.  We have posted a link to view and listen to the 30 minute webinar and posted a link to download a copy of the presentation slides.

You can find materials from past FDA Basics webinars here.

Afia Asamoah, Transparency Initiative Coordinator

New Updates on FDA-TRACK, Agency’s Performance Management System

January 12, 2011 24 comments

FDA’s performance management system, FDA-TRACK, allows the public to follow the agency’s progress on a range of measures (see April 7 blog  post).

New performance data from December 2010  is now available on FDA-TRACK.  Check out FDA-TRACK for updates, including complete FY 2010 data for projects related to human drugs and biological products, and animal drug products.

Afia Asamoah, Transparency Initiative Coordinator

FDA Launches Web-based Resource to Make Regulatory Information More Accessible

January 6, 2011 40 comments

Today, as part of the third phase of the Transparency Initiative, FDA launched a web-based resource called FDA Basics for Industry to provide basic information about the regulatory process, including information that is frequently requested by industry.  

FDA Basics for Industry includes:

  • Easier access to frequently requested content, including, guidance documents, information about the review process, and registration and listing information
  • Links to training modules for industry, such as the Center for Devices and Radiological Health’s CDRH Learn educational tool
  • Answers to questions frequently asked by industry

The launch of FDA Basics for Industry is one of the 19 steps outlined in a report issued today by the Transparency Task Force about ways FDA can improve its transparency to regulated industry.

Visit FDA Basics for Industry and let us know what you think.  You can leave a comment on this blog or send an email to

Afia Asamoah, Transparency Initiative Coordinator

Upcoming Event: FDA Basics Webinar by the Center for Tobacco Products on the State Enforcement Program, Tuesday, January 11, 2011 at 1 pm ET

January 5, 2011 12 comments

Did you know that the Family Smoking Prevention and Tobacco Control Act gives FDA the authority to contract with states and U.S. Territories to help with compliance and enforcement activities to help limit the availability of tobacco products to young people?

As part of FDA Basics, FDA is hosting a webinar where you can learn more.  The featured speaker, Ann Simoneau, Director of the Center for Tobacco Products Office of Compliance and Enforcement, will discuss the state enforcement program for tobacco.  After the presentation, there will be an opportunity to ask questions.

The free 30 minute webinar will be held Tuesday, January 11 at 1:00 pm ET.

There are a limited number of spots available for the webinar.  Materials from the webinar will also be made available on the FDA Web site following the presentation.

Click here for more information about the webinar, including instructions about how to join the webainr.

Afia Asamoah, Transparency Initiative Coordinator

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