CDER Small Business and Industry Assistance > CDER Small Business and Industry Assistance (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 Small Business and Industry Assistance (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

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The Food and Drug Administration, Center for Drug Evaluation and Research Small Business and Industry Assistance (CDER SBIA) is pleased to inform you of a unique opportunity for small business and industry entities to learn more about the FDA and basic drug regulation. Our webinar series highlights various aspects of drug regulation.

These focused webinars support CDER SBIA’s mission of promoting productive interaction with regulated industry by assisting small pharmaceutical business and industry with information relating to the development and regulation of human drug products.

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accompanying webinar which discusses the final guidance including changes that were made in response to comments on the draft guidance. 

 

Speaker:

Maryll W. Toufanian, J.D.

Director of the Division of Legal and Regulatory Support

Office of Generic Drug Policy

Office of Generic Drugs (OGD)

CDER/FDA

 

Maryll W. Toufanian, J.D., is Director of the Division of Legal and Regulatory Support, Office of Generic Drug Policy. Prior to joining OGD, she was Associate Chief Counsel for Drugs in FDA’s Office of Chief Counsel. Ms. Toufanian came to the Agency from Zuckerman Spaeder LLP, where her practice focused on food and drug law and criminal defense matters. 

 

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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