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Archive for August, 2010

Upcoming Event: FDA Public Webinar About the “510(k) Premarket Review Process” and the “Use of Science in Regulatory Decision Making” Draft Reports, Tuesday, August 31, 1:00 p.m. ET

August 26, 2010 5 comments

FDA recently published two preliminary reports conducted by the Center for Devices and Radiological Health (CDRH).  The first preliminary report is an assessment of the process used to review certain medical device applications before they are marketed (known as the 510(k) process) and draft recommendations.  The second preliminary report is an assessment of the use of science in CDRH's regulatory decision making and draft recommendations.  This is the first step in determining what, if any, improvements to these processes FDA may implement.

Next week, FDA is hosting a webinar where CDRH officials will discuss the details of both reports.  There will be an opportunity to ask questions.

The live webinar will be held on Tuesday, August 31, at 1:00 p.m. ET.

There are a limited number of spots available for the webinar.  Click here for more information about the webinar, which includes a link to join the webinar on August 31.

FDA is also soliciting comments from the public on the draft reports via www.regulations.gov, docket number FDA-2010-N-0348.

Afia Asamoah, Transparency Initiative Coordinator

Find out More About FDA: New Questions and Answers Available on FDA Basics

August 24, 2010 6 comments

Have you seen the term "FDA Advisory Committees" and wondered what they are and what they do?

Last week, FDA added six new questions about the advisory committee process to FDA Basics, the web-based resource that provides information about FDA and what the agency does. 

The questions include:

What is an FDA Advisory Committee?

How does an individual become a member of an FDA advisory committee?

What are the qualifications of a scientific member of an advisory committee?

How does the FDA use Advisory Committees to make decisions about drugs?

Find out answers to these questions and more in the "FDA Fundamentals" section of FDA Basics!  You can also rate how helpful the answer was.  We use this feedback to improve the answers and add more questions to FDA Basics.

Afia Asamoah, Transparency Initiative Coordinator

Materials Available from FDA Basics Webinar on “Using a Food Label to Make Smart Food Choices”

August 18, 2010 3 comments

Did you miss the FDA Basics webinar about how to use a food label to make smart food choices?

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

Check out the "What's New" box 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

What is FDA-TRACK?

August 11, 2010 10 comments

FDA has posted a video explaining FDA-TRACK, the performance management system the agency launched in April (see April 7 blog post).   FDA-TRACK is a web resource that provides information about the breadth of FDA's activities to promote and protect the public health.  

The video features FDA Principal Deputy Commissioner, Dr. Joshua Sharfstein and FDA Center Directors Drs. Bernadette Dunham and Janet Woodcock.  View the video below, then check out the information currently available on FDA-TRACK about FDA's progress on a range of activities and let us know what you think.

Upcoming Event: FDA Basics Webinar on Using a Food Label to Make Smart Food Choices, Tuesday, August 10, 1:30 p.m. ET

August 4, 2010 12 comments

What is "% DV" found on food labels and why is it important? What’s the relationship between serving size and total calories? 

As part of FDA Basics, FDA is hosting a webinar where you can learn more. The featured speaker, Essie Yamini, a nutritionist and a Registered Dietitian with a Ph.D. in nutritional biochemistry, works with the science review team at FDA’s Center for Food Safety and Applied Nutrition. Dr. Yamini will give an overview and answer questions about the Nutrition Facts Label.  After the presentation there will be an opportunity to ask questions.

The free 30 minute webinar will be held on Tuesday, August 10, at 1:30 p.m. ET.

Sign in early, since 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.

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

Afia Asamoah, Transparency Initiative Coordinator

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