News Focus
News Focus
Followers 42
Posts 4592
Boards Moderated 1
Alias Born 03/02/2007

Re: MinnieM post# 14000

Wednesday, 12/12/2012 11:10:09 PM

Wednesday, December 12, 2012 11:10:09 PM

Post# of 405172

You can find full details on S.3187 at http://hdl.loc.gov/loc.uscongress/legislation.112s3187, and you can find the language on breakthrough therapies in the bill by loading the full text of the legislation and reading in Section 902



Here's what it says:

"Title IX: Drug Approval and Patient Access - (Sec. 901) Expresses the sense of Congress that the FDA should apply accelerated approval and fast track provisions to expedite the development and availability of treatments for serious or life-threatening diseases or conditions while maintaining safety and effectiveness standards for such treatments.

(Sec. 902) Requires the Secretary, at the request of a sponsor of a drug, to expedite the development and review of such drug if the drug treats a serious or life-threatening disease or condition and the drug demonstrates substantial improvement over existing therapies (breakthrough therapy). "
Volume:
Day Range:
Bid:
Ask:
Last Trade Time:
Total Trades:
  • 1D
  • 1M
  • 3M
  • 6M
  • 1Y
  • 5Y