INFORMS Open Forum

Back to discussions
Expand all | Collapse all

New Research Reports Over One-third of Pre-Approved Prescription Drugs Have Not Completed the FDA Approval Process

  • 1.  New Research Reports Over One-third of Pre-Approved Prescription Drugs Have Not Completed the FDA Approval Process

    Posted 08-26-2019 11:20

    Key Takeaways from INFORMS journal Manufacturing & Service Operations Management:

    • More than one-third of the FDA's 'pre-approved' drugs have yet to complete the approval process.
    • Manufacturers are failing to complete post-market studies preventing them from being granted full, regular approval, but the drugs are still on store shelves.
    • Researchers propose a revised version of an already documented fee to ensure drugs get full approval in a timely manner.

     

    CATONSVILLE, MD, August 26, 2019 – The Food and Drug Administration's (FDA) Accelerated Approval Program was created in 1992 to significantly accelerate the ability to bring certain new drugs to market. New research published in the INFORMS journal Manufacturing & Service Operations Management reveals a large number of drug manufacturers are failing to complete the approval process, meaning a significant number of drugs on the market are not yet fully approved.

    Click here to read the full release.



    ------------------------------
    Ashley Smith
    INFORMS
    Catonsville MD
    ------------------------------


Related Content