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Titan Pharmaceuticals Inc. Message Board

  • stalyon52 stalyon52 Mar 8, 2013 9:18 AM Flag

    "breakthrough" product designation

    I wonder if TTNP & Braeburn have tried to file for "breakhrough" product designation?

    "The FDA's new "breakthrough" product designation allows new drugs to win approval after just a single round of testing, instead of the usual three. A total of three promising experimental medicines have been assigned the new status so far, while an additional 18 drugs have applied. The new designation follows three other programs -- Fast Track, Priority Review and Accelerated Approval -- each of which were designed to help bring crucial new drugs to market in a shorter amount of time.

    "A breakthrough drug is one that may offer important new benefits for patients with serious or life-threatening disease who are especially in need of new safe and effective treatments," said Janet Woodcock, director of FDA's Center for Drug Evaluation and Research."

    NOTE: The above was copied from headline on DNDN page. GLTA!

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