Reminder - CDER SBIA Webinar on Required Electronic Submissions: eCTD and Study Data – Thursday October 8, 2015

Reminder: CDER SBIA Webinar on Required Electronic Submissions: eCTD and Study Data – Thursday October 8, 2015

FDA’s CDER and CBER will host a webinar titled "Required Electronic Submissions: eCTD and Study Data"tomorrow, Thursday October 8, 2015, at 11AM EDT. Note that this webinar will be LIVE.

This one hour webinar will provide an overview of the final guidances and related technical specifications that implements the electronic submission requirements of section 745A(a) of the Federal Food Drug and Cosmetic Act (FD&C Act) for electronic submissions and study data contained in new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs), and investigational new drug applications (INDs). FDA will present the electronic Common Technical Document (eCTD) and study data requirements and the timeframes on the required submission of the eCTD and study data formats within the scope of the guidance.

Webinar Information

Registration

 For questions concerning the webinar, please contact CDER SBIA at:

(866)-405-5367 | (301)-796-6707

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 Test your connection prior to the day of the event:

https://collaboration.fda.gov/common/help/en/support/meeting_test.htm