Monthly Archives: 8 月 2014

U.S. FDA eSubmitter 實務之一 – WebTrader test account 申請

U.S. FDA 從2009年6月1日起, 除特別許可外,不再接受紙本的工廠註冊(Drug Establishment Registration)及產品登記(Drug Listing)。


1, 寄送紙本的Non-Repudiation Agreement Letter 到FDA, 同意FDA接受電子簽名的申請)。此信需用公司抬頭,手寫簽名,寄至

    Michael Fauntleroy
    Food and Drug Administration
    Center for Biologics Evaluation and Research
    11820 Parklawn Drive, Suite 300
    Rockville, MD 20852


2, 發送 email 到 申請WebTrader 測試帳號,並提供以下資料:

    Company name
    First and Last Name
    Phone Number
    Submission Method: (WebTrader)
    Indicate if you would like a WebTrader Hosted Solution (WTHS) account in addition to your WebTrader account. (For more information on WTHS accounts please click here26).

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