FDA approval for Breakthrough Therapy – how does it work?

Discussion Board Forums Clinical Trials FDA approval for Breakthrough Therapy – how does it work?

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    marions
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    Too often we wonder why a drug is not reaching the patient population quickly.

    In order for drugs to reach the patient population, Pharmaceutical companies must adhere to strict standards set by the FDA. Serious conditions i.e. Cholangiocarcinoma etc. can be designated for fast approval if the following conditions are met:
    1. Early on it must be evident that the drug clearly is superior to the existing therapies
    2. Request for breakthrough is submitted, FDA will respond within 60 days
    3. FDA senior specialists work closely with Pharma
    4. Drug will be withdrawn if not all criteria set forth by FDA is met.

    The below link including the downloadable power point presentation allows for understanding of the process necessary to bring life saving drugs to the patient population:
    http://www.healthaffairs.org/healthpolicybriefs/brief.php?brief_id=115

    Hugs,
    Marion

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