martes, 26 de agosto de 2014

New web-based learning course - “Human Drug Establishment Registration and Drug Listing Compliance”

FDA/CDER's Small Business and Industry Assistance (CDER SBIA)

“Human Drug Establishment Registration and Drug Listing Compliance”
Web-Based Learning Course 
CDER SBIA announces the launch of another web-based learning course as part of our Small Business and Industry Education Series, titled Human Drug Establishment Registration and Drug Listing Compliance.”
The overall goal of this training module is to provide manufacturers and distributors of human drugs a clearer understanding of the procedures and regulations for electronic registration and listing of U.S. commercially distributed drugs. We hope that you utilize this training as a resource to not only identify business operations that must be registered and drug products that must be listed, but to also become knowledgeable on how to accomplish these requirements.
This course is a great resource to refer to for guidance regarding drug establishment registration and drug listing. We hope that you find it helpful.
Additional courses will be posted on our Small Business and Industry Education Series page as we develop them.

The Small Business and Industry Assistance program in the Center for Drug Evaluation and Research (CDER SBIA) provides guidance and information to regulated domestic and international small pharmaceutical business and industry 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 CDER SBIA staff. If you have comments or questions, please contact us Monday through Friday 8:00AM - 4:30PM.
Please take our CDER Small Business survey:

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