CDER SBIA Chronicles: GDUFA - Where Are We Now?

The Small Biz Buzz
The Information Source for Regulated Domestic and International Small Pharmaceutical Business and Industry

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CDER SBIA Chronicles: GDUFA – Where Are We Now? 

The topic of this month’s issue of the FDA/CDER Small Business Chronicles: GDUFA – Where Are We Now?

The Generic Drug User Fee Amendments of 2012 (GDUFA) had some challenging goals when it was first introduced in September 2012. By September 30, 2017, GDUFA requires FDA to review and act on 90 percent of complete electronic original generic applications within 10 months after the date of submission. Read this newsletter to find out how we are measuring up.

The purpose of this newsletter, the FDA/CDER SBIA 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 CDERSBIA@fda.hhs.gov. 

Our previous newsletters are also archived on our webpage at: http://www.fda.gov/cdersmallbusinesschronicles.

  

Enjoy!

The CDER Small Business and Industry Assistance Team 

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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