FDA Guidance Finalizes Generic Drug Makers’ Process for Communicating with the Agency


This week FDA finalized its draft guidance on Controlled Correspondence Related to Generic Drug Development. Although all submitted comments were considered, FDA’s revised the draft to “provide clarifying and explanatory information that will assist human generic drug manufacturers and related industry as they submit controlled correspondence to FDA.” The following additions were included in the final guidance:

  • A Description of a process to submit information to update the Agency’s Inactive Ingredient Database.
  • A Description of enhanced communication to requestors regarding the status of their controlled correspondence.

Additionally, the guidance excluded three types of inquiries that will continue to be treated differently from other generic drug development inquiries even though they technically fall under the definition of controlled correspondence. These include: “(1) requests for recommendations on the appropriate design of BE studies for a specific drug product (BE guidance requests); (2) requests for review of BE clinical protocols (clinical protocol requests); and (3) requests for meetings to discuss generic drug development prior to ANDA submission (pre-ANDA meeting requests).”

Have you developed, or are you in the process of developing, a generic product? Need assistance submitting correspondence and information requests to FDA? We can help you through the entire process, from the initial communication to receiving FDA approval for your product. To learn more about our services and how we can help you, email us here.