The Small Biz Buzz
The Information Source for Regulated Domestic and International Small Pharmaceutical Business
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:
https://collaboration.fda.gov/sba32513/event/registration.html
(Registration password needs to be 8 characters and alphanumeric)
Web Address for Viewing:
https://collaboration.fda.gov/sba32513/event/registration_login.html
(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
The Small Business Assistance (SBA) program in the Center for Drug Evaluation and Research (CDER) provides guidance and information to regulated domestic and international small pharmaceutical business through its website, email notifications, and workshops. This notification system provides current information from CDER/FDA via e-mail on a biweekly basis that is relevant to small pharmaceutical business, which includes Federal Register notices, guidances, workshop announcements, etc. This is an automated message delivery system. Replying to this message will not reach the SBA staff. If you have comments or questions, please contact us Monday through Friday 8:00AM – 4:30PM. Please take our CDER Small Business survey: https://www.surveymonkey.com/s/cdersmallbusiness
| This email was sent to kostikblog@ukr.net using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420 |  |
