CDER SBIA Webinar - Final Guidance for Industry on Controlled Correspondence Related to Generic Drug Development - September 28, 2015

CDER Small Business and Industry Assistance (CDER SBIA) Webinar - Final Guidance for Industry on Controlled Correspondence Related to Generic Drug Development - September 28, 2015

On September 28, 2015, FDA published the Final Guidance for Industry on Controlled Correspondence Related to Generic Drug Development. CDER SBIA is making available the accompanying webinar which discusses the final guidance including changes that were made in response to comments on the draft guidance.

For questions concerning the webinar, please contact CDER SBIA at:

(866)-405-5367 | (301)-796-6707

Federal Register notice

CDER SBIA webinar series

OGD homepage

Presentation Information:

- Controlled Correspondence Related to Generic Drug Development

View Webinar (Adobe Connect link)

- Controlled Correspondence (PDF - 287KB)

Download Presentation Slides

- Controlled Correspondence Related to Generic Drug Development - Audio file only (MP3 - 8.1MB) Listen to Presentation

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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 SBIA survey: https://www.surveymonkey.com/s/CDERSBIA_Evaluation