FDA Releases Guidance for Platform Technology in Drug Applications

The FDA has introduced guidance for platform technology designations that is designed to streamline regulatory processes for biotech companies using ‘well-understood and reproducible technology’, such as specific nucleic acid sequences, vectors or delivery methods, to expedite subsequent drug applications. The guidance, developed by the FDA’s CDER and CBER, requires companies to submit detailed information during the IND phase.

This guidance provides details about the implementation of the platform technology designation program established by section 506K of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This guidance outlines eligibility factors for receiving a platform technology designation, potential benefits of receiving a designation, how to leverage data from designated platform technologies, how to discuss a planned designation request as part of a milestone meeting, the recommended content of a designation request submission, and the review timelines for a designation request. This program is intended to result in efficiencies in drug development, manufacturing, and review processes for drug product applications that incorporate designated platform technologies.

For more, please find the original guidance document here.