FDA: New Plan to Speed Drug Development Print E-mail
By Staff and Wire Reports   
Thursday, 27 December 2012 12:15

icon_newslinkThe FDA has issued guidance outlining how drug companies can select patients more likely to show a benefit from a studied drug and how companies can help improve the speed and efficiency of clinical trials.

In draft guidance published last week, the agency outlined specific examples of how drug developers can exclude poor potential candidates and select those more likely to show a clinical benefit.

For instance, if a drug company is studying a lipid-lowering drug meant to reduce heart attack risk, it may choose diabetic patients because they're more likely to have heart attacks and show an effect from the drug.

The FDA called these types of study designs "enrichment strategies" or "enriched studies."

"These are potentially powerful strategies for the pharmaceutical industry because appropriate use of enrichment could result in smaller studies, shortened drug development times, and lower development costs," Bob Temple, MD, deputy director for clinical science in the FDA's Center for Drug Evaluation and Research, wrote in a blog post on the agency's website.

The 42-page guidance listed several examples of ways enriched studies have been used to approve drugs already.  More From MedPage.




"Featured Content" profiles are meant to provide awareness of these companies to investors in the small-cap and growth equity community and should not in any way come across as a recommendation to buy, sell or hold these securities. BiomedReports is not paid or compensated by newswires to disseminate or report news and developments about publicly traded companies, but may from time to time receive compensation for advertising, data, analytics and investor relation services from various entities and firms. Full disclosures should be read in the 'About Us Section'.

Add this page to your favorite Social Bookmarking websites
Digg! Reddit! Del.icio.us! Mixx! Google! Live! Facebook! Technorati! StumbleUpon! MySpace! Yahoo!

blog comments powered by Disqus
 

Newsletter