FDA Draft Guidance for Industry and Pre-Recorded Webinar:
Controlled Correspondence Related to Generic Drug Development
Today FDA published a notice in the Federal Register announcing the availability of a new draft guidance for industry: Controlled Correspondence Related to Generic Drug Development
This guidance provides information regarding the process by which generic drug manufacturers and related industry can submit correspondence to FDA requesting information related to generic drug development. This guidance also describes FDA’s process for providing communications related to such correspondence. FDA is issuing this draft guidance as part of the Agency’s implementation of the Generic Drug User Fee Amendments of 2012.
A pre-recorded webinar explaining this draft guidance is available at:
CDER Small Business and Industry Assistance (CDER SBIA) Webinar “Draft Guidance for Industry on Controlled Correspondence Related to Generic Drug Development” – August 26, 2014
Submit electronic comments on the draft guidances to the Federal Register docket.
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.
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