The Small Biz Buzz
The Information Source for Regulated Domestic and International Small Pharmaceutical Business
FDA/CDER Small Business Chronicles – BsUFA
The topic of this month’s issue of the FDA/CDER Small Business Chronicles is the Biosimilar User Fee Act of 2012 (BsUFA). In this issue, we discuss the background of BsUFA, performance goals, and associated fees.
The purpose of the newsletter, the FDA/CDER Small Business Chronicles, is to provide industry with useful information to assist in all aspects of drug marketing and regulation.
As always, we would appreciate your input regarding topics that you would like us to write about. If you have topics of interest, please email us at CDERSmallBusiness@fda.hhs.gov.
Our previous newsletters are also archived on our webpage at: http://www.fda.gov/cdersmallbusinesschronicles.
Enjoy!
The CDER Small Business Assistance Team
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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