The Small Biz Buzz
The Information Source for Regulated Domestic and International Small Pharmaceutical Business and Industry
Introducing CDER SBIA
We are excited to launch our program’s new name, which more accurately recognizes the true audience that we serve: small pharmaceutical business AND industry. Formerly known as the CDER Small Business Program, we will now be known as CDER Small Business and Industry Assistance (CDER SBIA).
CDER SBIA’s mission is to promote productive interaction with regulated domestic and international small pharmaceutical business and industry by providing timely and accurate information relating to the development and regulation of human drug products.
Be sure to bookmark our new web address at http://www.fda.gov/cdersbia.
Check out the Spotlight box to learn about some of the services we provide:
- Workshops and Webinars: We offer at least two workshops per year and many webinars on regulatory hot topics, all of which are free.
- Small Business and Industry Education Series: We offer a group of Web-based tutorials aimed at educating small pharmaceutical business and industry on topics relating to drug regulation and review.
- CDER SBIA Chronicles: We publish a bimonthly newsletter that provides industry with useful information to assist in all aspects of drug marketing and regulation.
In addition, you may reach CDER SBIA staff with your regulatory questions via email or phone.
Email: CDERSBIA@fda.hhs.gov
Phone: (866)-405-5367 or (301)-796-6707
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.
- Email: CDERSBIA@fda.hhs.gov
- Phone: 1-866-405-5367
- Phone: (301) 796-6707
- Website: http://www.fda.gov/cdersbia
Please take our CDER Small Business survey: https://www.surveymonkey.com/s/CDERSBIA_Evaluation
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