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Archive for April, 2010

Upcoming Events: FDA Basics Webinar on Safeguarding the U.S. Food Supply, Excellent Industry Compliance with the Final Bovine Spongiform Encephalopathy (BSE) Rule, April 22, 2 p.m. E.T.

April 20, 2010 7 comments

Did you know that FDA works to keep the food supply in the U.S. safe for people and animals? Everyday, FDA is protecting people by making sure that the food they eat comes from healthy animals.

As part of FDA Basics, FDA is hosting a webinar where you can learn more.  Featured speakers Shannon Jordre, Consumer Safety Officer and Burt Pritchett, Veterinary Medical Officer from the Division of Compliance, Center for Veterinary Medicine, will discuss animal feed controls FDA has put in place to keep BSE out of the U.S. cattle population, thereby ensuring the safety of the nation’s food supply from BSE.  After the presentation, there will be a chance to ask questions.

The free 30 minute webinar will be held on Thursday, April 22, at 2 p.m. ET.

You can find out more information about the webinar, including how to participate in the webinar on the FDA Basics homepage.  Click here for more information about the webinar.

Afia Asamoah

Transparency Initiative Coordinator

FDA Launches Medical Device and Radiation-Emitting Product Transparency Web Site

April 19, 2010 21 comments

Today, the U.S. Food and Drug Administration (FDA) launched the Center for Devices and Radiological Health (CDRH) Transparency Web site in support of the agency’s Transparency Initiative.  This site will provide information about medical device and radiation-emitting product regulatory processes and decisions, and summaries of data to support those decisions.

The new Web site is part of an ongoing effort within FDA to enhance communication and transparency.  This Web site makes available new information about CDRH’s decision-making processes and displays this information in a more user-friendly format.  The site includes new information such as:

  • basic information about medical devices and how FDA regulates those products
  • information about medical devices before and after the products are on the market, in a searchable database
  • information about the clinical studies and trials conducted to demonstrate the safety and effectiveness of certain medical devices
  • memos from FDA employees explaining the reasons for the agency’s decisions about medical device manufacturer requests to make a significant change in components, materials, design, specification, software, color additive, and labeling of a medical device
  • a step-by-step guide for manufacturers of radiation-emitting products to assist with the regulatory process

CDRH plans to add new information about premarket submissions, product performance & safety, compliance & enforcement, and science & research to this website monthly.

The Web site includes a feedback feature that will allow CDRH to collect input and suggestions from the public about the information provided.  Visit the CDRH Transparency Web site at www.fda.gov/CDRHTransparency and let us know what you think.  Feedback provided will be used to improve and expand the website.

Afia Asamoah

Transparency Initiative Coordinator

FDA Launches a New Website to Make Information about the Work of FDA’s Program Offices Available

April 7, 2010 36 comments

Today, FDA launched a new website that will help the public understand the breadth of FDA's core responsibilities to promote and protect the public health.  The website is called FDA-TRACK: Agency-wide Program Performance.  FDA-TRACK is FDA's new agency-wide performance management and accountability tool. 

The FDA-TRACK website will allow you to gain insights about:

  • Each of our program offices and what they do
  • Each program office's key performance goals and projects

On a quarterly basis, each FDA program office will submit monthly performance data and present that information to FDA senior leadership. This information will be posted on the FDA-TRACK website and the public can track this information and monitor the accomplishments and trends for each key program area. 

Visit the FDA-TRACK website resource at http://www.fda.gov/fdatrack and let us know what you think. You can suggest changes and let us know if you found the information to be useful by emailing FDATRACK@fda.hhs.gov.  Feedback you provide may be used to improve the program.

Malcolm Bertoni, Assistant Commissioner for Planning at FDA

 

Transparency to Regulated Industry: Communicating with Sponsors During FDA’s Review of the Product Application

April 2, 2010 4 comments

The Task Force is collecting information on how to improve FDA's transparency to regulated industry.  We held three listening sesions with members of regulated industry on January 21, 27, and 28.  Transcripts and summaries of those listening sessions are available online and we are seeking comments from the public on the issues raised in those sessions, or other suggestions related to FDA's transparency to regulated industry. 

Our next question is:

What information, if any, should FDA provide to sponsors during the agency's review of the sponsor's product application?

We look forward to your ideas.

Transparency Task Force

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