FDA Hepatitis Update - FDA launches new clinical trials demographic data page - seeking comments

"U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx> · Mon, 24 Nov 2014 09:34:33 -0600

Title:     FDA Hepatitis Update - FDA launches new clinical trials demographic data page - seeking comments

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  FDA recently released a new internet web page that is intended to provide easy to understand demographic data for consumers including the age, race, and sex of participants in clinical trials for FDA-approved drugs and biologics.  
The information will be organized in a new document that FDA is calling Drug Trials Snapshots.  Each Snapshot covers a single drug, providing a breakdown of the  percentage of demographic subgroups participating in the drug’s pivotal  clinical trials. 
Also included is information about how the trial was designed  and whether there were any observed differences in side effects and  efficacy by sex, age and race/ethnicity.
Initially, FDA is posting a Snapshot of six new molecular  entities (NMEs) that were approved by FDA between May and June 2014.  Beginning next year, we intend to post a Snapshot for every approved NME  and original biologic.  
FDA is seeking feedback from the public on the content, format  and overall usability of the first six Snapshots. We welcome your  comments. 
You can comment on the content, format, and overall usability of the Drug Trials Snapshots [Docket No. FDA-2014-N-1818] at:
 https://s3.amazonaws.com/public-inspection.federalregister.gov/2014-27732.pdf
More about the Drug Trials  Snapshots:
 http://www.fda.gov/Drugs/NewsEvents/ucm424178.htm 
The creation of this web page was one of the 27 action items in FDA’s 2014 Action Plan to Enhance the Collection and Availability of Demographic Subgroup Data, issued in August.
Richard Klein
 Office of Health and Constituent Affairs
 Food and Drug Administration
Kimberly Struble
 Division of Antiviral Products
 Food and Drug Administration
Steve Morin
 Office of Health and Constituent Affairs
 Food and Drug Administration

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