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? – March 25, 2013
On Monday March 25, 2012, at 11 AM EDT, the CDER Small Business Assistance Program will present a webinar entitled What's New with the 356h Form?
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.
Our presenter will be Beth Duvall, who is the Associate Director for Regulatory Affairs in the Office of New Drugs Immediate Office (OND IO) in the Center for Drug Evaluation and Research (CDER), FDA. In her position, Beth manages the Regulatory Affairs Team (RAT) in OND IO that is responsible for implementing and overseeing 21st Century Review processes and PDUFA V provisions, including the Enhanced Communications Team and Breakthrough Therapy designation requests, and for providing support and oversight for the DARRTS Program, Formal Dispute Resolution, OND Process Improvements, and other cross-cutting initiatives within CDER. Ms. Duvall earned a B.S. Degree in Chemistry (minor in mathematics) from the University of Delaware.
To register for this Event, please go 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
Please refer to this chart for your country code: Dial-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
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