The Small Biz Buzz
The Information Source for Regulated Domestic and International Small Pharmaceutical Business
New web-based learning course-
“Electronic Common Technical Document (eCTD): Overview and Submission”
FDA/CDER’s Small Business Assistance Program announces the launch of its first CDERLearn web-based learning courses, “Electronic Common Technical Document (eCTD): Overview and Submission.”
Learn from the source! This course will explain, with precise detail, CDER’s policies and practices regarding electronic submissions and will guide you through the appropriate steps to transition your applications (old and new) to the eCTD format. It will address the essential steps of submitting electronic submissions to CDER, and is a great resource for questions about the submission process.
We hope that you find it helpful. Additional courses will be posted on our Small Business CDERLearn page as we develop them.
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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