Home > Transparency Posts > FDA Launches Webpage with Summaries of Safety Data on New Drugs

FDA Launches Webpage with Summaries of Safety Data on New Drugs

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

  1. carolyn spector
    June 18, 2010 at 8:47 pm

    Here are some databases:
    http://www.askapatient.com/
    These should be taken under the wing of the FDA and CDC and developed.
    The other one is ssristories.com.

  2. carolyn spector
    June 18, 2010 at 8:50 pm

    This data base needs to be taken under the wing of the FDA.
    This website is a collection of 3900+ news stories with the full media article available, mainly criminal in nature, that have appeared in the media (newspapers, TV, scientific journals) or that were part of FDA testimony in either 1991, 2004 or 2006, in which antidepressants are mentioned.
    http://www.ssristories.com/

  3. Mariaokao22
    June 30, 2010 at 5:34 am

    Great info! I am really interested in it. Thanks!
    http://www.insuranceportstlucie.com/

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    July 15, 2010 at 10:30 am

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    July 23, 2010 at 5:14 am

    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. 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, superb and nice article, Thanks.

  6. Mic Melatrol
    July 29, 2010 at 7:07 pm

    Very cool about the FDA creating and posting the safety information about the approved drugs to help us have access to any safety issues that may be associated with them.

  7. September 24, 2010 at 11:50 pm

    Stellar blog, would love to see a bit more media though! One of my favorite subjects… Then again my site hasn’t very much either – Great post anyway, added your XML feed! Cheers

  8. February 4, 2011 at 6:47 am

    This is a visible evidence of how transparent this institution can be. Thanks!
    bobby jones

  9. September 20, 2011 at 9:42 pm

    The new website with new drugs safety data looks very good and seems very useful!

  10. Katy Perry Candy Dress
    September 26, 2011 at 9:39 pm

    This is a very nice initiative… I’ve been waiting for a resource like this for years! Thanks.

  11. July 24, 2012 at 10:39 pm

    Life would be so much better if things were more transparent in our lives like this.

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