Controlled Correspondence Related to Generic Drug Development

This Information Collection Request (ICR) supports agency guidance. The guidance document provides recommendations for generic drug manufacturers and related industry who wish to submit a controlled correspondence related to generic drug development to the Food and Drug Administration (FDA). The guidance document supports FDA's commitments under the Generic Drug User Fee Amendments.

The latest form for Controlled Correspondence Related to Generic Drug Development expires 2023-06-30 and can be found here.