Controlled Correspondence Related to Generic Drug Development

21 December 2022 – the FDA published draft guidance on controlled correspondence related to generic drug development.

This guidance provides information regarding the process by which generic drug manufacturers and related industry or their representatives can submit to FDA controlled correspondence requesting information related to generic drug development. This guidance also describes the Agency’s process for providing communications related to such correspondence.

Read more online 
Copyright Widler & Schiemann AG 2022. All Rights Reserved. /