Division of Clinical Research

Office of the Vice President and Innovation

Category results for: generic drugs

FDA Publishes Final Guidance for Controlled Correspondence Related to Generic Drug Development

On December 16, 2020, FDA announced the availability of the final guidance for industry entitled “Controlled Correspondence Related to Generic Drug Development.” This final guidance provides information on the following: Process by which generic drug manufacturers and related industry can submit controlled correspondence to FDA requesting information related to generic drug development Agency communications related […]

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