% | $
Quotes you view appear here for quick access.


  • dsroyal91 dsroyal91 Jan 17, 2013 8:15 PM Flag

    FDA Meeting Feb 4th and 5th

    The blood platelets are probably the topic.

    Creating an Alternative Approval Pathway for Certain Drugs Intended to Address Unmet Medical Need; Public Hearing
    The Food and Drug Administration (FDA) is announcing a public hearing to obtain input on a potential new pathway to expedite the development of drugs, including biological products, for serious or life-threatening conditions that would address an unmet medical need. The drug’s safety and effectiveness would be studied in a smaller subpopulation of patients with more serious manifestations of a condition. Such a pathway could involve smaller and more rapid clinical trials than would occur if the drug were studied in a broader group of patients with a wide range of clinical manifestations. The labeling of drugs approved using this pathway would make clear that the drug is narrowly indicated for use in limited, well-defined subpopulations in which the drug’s benefits have been shown to outweigh its risks. The purpose of the public hearing is to obtain information and comments from the public on the need for and feasibility of this pathway and its potential advantages and disadvantages.

    Date: Februrary 4-5, 2013

    Time: 9:00 a.m. to 4:00 p.m.

    Location: FDA White Oak Campus
    10903 New Hampshire Avenue, Bldg. 31 Rm. 1503
    Silver Spring, Maryland 20993

    Federal Register Notice1
    Visitor Information

    All meeting attendees must enter through Building 1 on the FDA White Oak Campus. Parking is available in the Southeast surface lot and a shuttle bus will be available to bring attendees from the lot to Building 1. Please see Directions/Transportation/Parking/Hotels for the FDA White Oak Campus (PDF - 115KB)2 for directions and further details about transportation and lodging. Map of White Oak Visitor Parking (PDF - 105KB)3

    Webcast of Meeting

    For those unable to attend in person, the meeting will also be shown via webcast. Watch the webcast on February 4th and 5th from 9:00 am to 4:00 pm. Requirements and instructions for accessing the webcast are below. Please be sure to download the most up-to-date version of Flash Player.

    Sentiment: Strong Buy

    SortNewest  |  Oldest  |  Most Replied Expand all replies