martes, 18 de febrero de 2014


The Small Biz Buzz
The Information Source for Regulated Domestic and International Small Pharmaceutical Business and Industry
FDA/CDER's Small Business and Industry Assistance (CDER SBIA)


CDERWorld is a series of educational modules based on The CDER Forum for International Regulatory Authorities Lectures.  The modules present an overview of the work of the Center for Drug Evaluation and Research. After a hiatus, CDERWorld is alive again on our website.

For many years, FDA/CDER has reached out to its international regulatory colleagues. Since 2005, CDER has held the CDER Forum for International Drug Regulatory Authorities every spring and fall so international regulators can learn first-hand how CDER organizes the drug review process and carries out its mission of ensuring the safety and efficacy of human drug products in the United States.

The interest in these "live" meetings has grown exponentially with FDA working in harmonization with countries around the world. Many more people than can be accommodated at these small meetings want to learn about the science, technology, regulations and processes CDER uses to accomplish its complex and challenging work. To respond to this great interest, the Center has developed CDER World.

CDER World is an ever-growing compendium of information about how CDER carries out its mission, adapts to new legislative initiatives, and initiates directions in regulatory science to improve the public health. Please take some time to check out this excellent resource!

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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