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Archive for June, 2010

Upcoming Events: FDA Basics Webinar on FDA’s Regulation of Tobacco Products — the Year in Review and Looking Forward, Tuesday, June 29, 11 a.m. ET

June 24, 2010 23 comments

Did you know that FDA was given the authority to regulate tobacco products last year? Do you want to learn about steps FDA has taken since that time?

As part of FDA Basics, FDA is hosting a webinar where you can learn more. The featured speaker, Lawrence R. Deyton, M.S.P.H., M.D., Director, Center for Tobacco Products, will discuss several important steps FDA is taking in a coordinated effort to prevent our children from becoming the next generation of Americans to die prematurely from tobacco use and ultimately reducing death and disease associated with tobacco use. After the presentation there will be an opportunity to ask questions.

The free 30 minute webinar will be held on Tuesday, June 29, at 11 a.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

New FDA Basics Video Available about Orphan Drugs and the Fight Against Rare Diseases

June 21, 2010 32 comments

As part of FDA Basics, FDA has posted a new video with Dr. Tim Cote, director of FDA’s Office of Orphan Products Development.  Dr. Cote discusses how FDA’s Orphan Drugs program helps in the fight against rare diseases.  View the video below.

FDA Launches Webpage with Summaries of Safety Data on New Drugs

June 17, 2010 17 comments

On Tuesday, June 15, FDA launched a web page where you can find summaries of safety information about recently approved drugs and a brief discussion of any steps FDA may be taking to address any identified safety issues. New drugs approved after September 27, 2007 will receive a safety summary within roughly two years of approval. The summaries address safety risks that were not identified during a drug's development or prior to FDA approval. FDA plans to publish summaries on a quarterly basis.

The first set of safety summaries for 26 products approved in 2008 can be found here.

You can find questions and answers about FDA's plan to post safety summaries here.

Afia Asamoah, Transparency Initiative Coordinator

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

June 15, 2010 8 comments

In May, based on comments from the public, FDA added 12 new questions to FDA Basics, the web-based resource that provides information about FDA and what the agency does.

Have you wondered how many people work at FDA?

Do you know what to do with medicine you no longer need?

Do you know if FDA has a definition for the term "organic" on food labels?

Find out answers to these questions and more at FDA Basics!  

Afia Asamoah, Transparency Initiative Coordinator

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