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  • 1.  Search Drug/Biologic/Device Approvals by key word?

    Posted 05-May-2017 11:06
    I there a way to search by keyword for drug/biologic/device approvals during a certain period of time?  I can't seem to find a way that I feel is actually capturing everything there is, either all classifications together or individually.  Any advice would be really appreciated!

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    Marcy Sussman RAC
    Director, Regulatory Affairs North America
    Infirst Healthcare
    Potomac MD
    United States
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  • 2.  RE: Search Drug/Biologic/Device Approvals by key word?

    Posted 05-May-2017 17:38
    Below link is specifically for Drug approvals by months

    Drugs@FDA: FDA Approved Drug Products
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    Drugs@FDA: FDA Approved Drug Products
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    Below link is for Medical devices:

    Recently-Approved Devices


    Below link is for biologics:

    Biological Approvals by Year

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    Biological Approvals by Year
    The Center for Biologics Evaluation and Research (CBER) regulates products under a variety of regulatory authorities. The annual biological approvals are broken into lists based on these regulatory authorities. See the Development and Approval Process page for a description of what types of products are regulated at Biologics License Applications (BLAs), Premarket Approvals (PMAs), New Drug Applications (NDAs) or 510(k)s.
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    Gaurang Bhavsar
    Edison NJ
    United States
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    Original Message


  • 3.  RE: Search Drug/Biologic/Device Approvals by key word?

    Posted 07-May-2017 18:54

    I use a subscription based tool called Pharmapendium which allows for keyword searches in FDA approval packages, FDA advisory committee documents and EPARs from EMA.

     

    Linda BOWEN

    Chair NJ NY RAPS Chapter

     




    Original Message


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