The
Division of Drug Information (DDI) is CDER's focal point for public
inquiries. We serve the public by providing information on human drug
products and drug product regulation by FDA.
CDER Small Business Webinar on What's New with the 356h Form? – April 8, 2013
We have rescheduled our webinar entitled What's New with the 356h Form for Monday April 8, 2013, at 11 AM EDT. If you previously registered for the webinar that was postponed, please re-register.
This
Webinar will acquaint participants with recent changes that have been
made to FDA Form 356h which accompanies all regulatory submissions
associated with New Drug Applications (NDAs), Biologic License
Applications (BLAs), Abbreviated New Drug Applications (ANDAs), and
supplements to approved applications. We will provide an overview of the
changes that were made and then walk participants through the various
fields of the form, populated with mock-data, while providing
instructions as to what information is to be captured in each field.
Time for questions from participants will be allotted at the end of the
Webinar.
To register for this event, please go to the following link:
(Registration password needs to be 8 characters and alphanumeric)
Web Address for Viewing:
(Presentation will last approximately 1 hr)
Call in Numbers (listen only):
Domestic: 1-866-844-9416
International: 1-203-369-5026
Country Codes: Call in Numbers (PDF - 24KB)
Password (verbal): FDA
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