The FDA published a revised guidance issue today (here) that revises a December 2020 guidance on Controlled Correspondence (CC) by the Office of Generic Drugs. This December 2020 guidance is being updated to reflect the new provisions of GDUFA III and its commitment letter relative to the submission of CC.
“This guidance provides information regarding the process by which generic drug manufacturers and related industry can submit to FDA controlled correspondence requesting information related to generic drug development and the Agency’s process for providing communications related to such correspondence.” (See the FR notice here.) In addition, it informs industry as to how to obtain clarifications of ambiguities in FDA responses to CCs as well as the process, including anticipated timelines for OGD response based on review goals for GDUFA III as outlined in the commitment letter. It also describes the circumstances under which an applicant can submit a CC after receipt of a complete response letter, which is another new aspect of GDUFA III implementation.
There is lot of good information in this guidance, and it will undoubtably help ensure that industry can meet the FDA’s requirements for submission of CCs and help better determine when CCs are appropriate, when they can be used, and the process by which the FDA will respond, along with current timelines for responses to Levels 1 and 2 and to those in need of clarification to CCs.
