USFDA Draft Guidance for Industry: Controlled Correspondence Related to Generic Drug Development

Today FDA published a notice in the Federal Register announcing the availability of a new draft guidance for industry: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  FDA is issuing this draft guidance as part of the Agency’s implementation of the Generic Drug User Fee Amendments of 2012.

A pre-recorded webinar explaining this draft guidance is available at:

CDER Small Business and Industry Assistance (CDER SBIA) Webinar “Draft Guidance for Industry on Controlled Correspondence Related to Generic Drug Development”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.

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