Monday, July 09, 2012

FDA Safety and Innovation Act

I saw this mentioned on the BIOtechNOW site today - an op-ed piece by the President and CEO of NORD, Peter L. Saltonstall:
http://www.biotech-now.org/health/2012/07/fda-safety-and-innovation-act-a-monumental-step-forward-for-patients-with-rare-diseases

I am not sure how this will take action at the individual level - after all, no one has ever asked me for my Rare Disease card, so I am not sure how they are qualifying the population that is supposed to be included in treatment. However, if the work of NORD resulted in the FDA making funding available for rare disease research, they have my vote of thanks. Now, if that FDA support transfers to the actual drug and medical device manufacturers, then I will be cheering us all on. Maybe I can apply to be a trainer for the "enhanced staff training for FDA reviewers with regard to orphan product reviews", or become a virtual librarian as a member of the "increased staffing and expansion of the Rare Disease Program in CDER and CBER".

Other news covering this passed act:

FDA safety and innovation act is passed in Deleware: http://www.communitypub.com/news/x537695762/FDA-safety-and-innovation-act-is-passed-in-Delaware

FDA safety and innovation act signed (NORD press release)
http://www.marketwatch.com/story/fda-safety-and-innovation-act-signed-a-monumental-step-toward-the-development-of-safe-and-effective-treatments-for-millions-of-americans-with-rare-diseases-2012-07-09


San Diego-based West Wireless Health Institute, BIOCOM, and CONNECT applaud President Obama signing FDA User Fee Bill into law http://www.marketwatch.com/story/san-diego-based-west-wireless-health-institute-biocom-and-connect-applaud-president-obama-signing-fda-user-fee-bill-into-law-2012-07-09

Pew Commends US Congress for Passing FDA User Fee Legislation (press release predates today's presidential signing) http://www.marketwatch.com/story/pew-commends-us-congress-for-passing-fda-user-fee-legislation-2012-06-26

FDA gets device, but not drug tracking
http://www.fiercepharmamanufacturing.com/story/fda-gets-device-not-drug-tracking/2012-07-05

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