martes, 28 de mayo de 2024

Platform Technology Designation Program for Drug Development MAY 2024 Today, FDA issued the “Platform Technology Designation Program for Drug Development” draft guidance. The platform technology designation program was added to the Federal Food, Drug, and Cosmetic Act by the PREVENT Pandemics Act. This program is intended to result in efficiencies in drug or biological product development, manufacturing, and review processes for drugs and biological products incorporating designated platform technologies. Today’s guidance outlines how a well-understood and reproducible technology in an FDA-approved drug or biological product may be eligible for a platform technology designation. There are several potential benefits for a drug company that receives a platform technology designation, including having early and additional interactions with FDA to discuss the use of a platform technology and leveraging information previously submitted in support of the designation in subsequent submissions from the same sponsor, such as new drug or biologics license applications. Read the guidance for the complete eligibility factors for receiving a platform technology designation, the 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.

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