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USFDA Guidance: Platform Technology Designation Program for Drug Development

Today (29 May 2024) the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research issued draft guidance for the "Platform Technology Designation Program for Drug Development"

The guidance outlines the criteria for receiving a platform technology designation, potential benefits of receiving a designation, how data from designated platforms can be leveraged, how to discuss a planned designation request during a milestone meeting, what should be included in a designation request submission, and when it should be reviewed.

The purpose of this program is to achieve efficiencies in drug development, manufacturing, and review processes for drug products incorporating designated platform technologies.

Platform Technology: As defined in section 506K(h)(1) of the FD&C Act, a well-understood and reproducible technology, which can include a nucleic acid sequence, molecular structure, mechanism of action, delivery method, vector, or a combination of any such technologies that the Secretary determines to be appropriate, that the sponsor demonstrates

  1. is incorporated in or used by a drug and is essential to the structure or function of such drug;

  2. can be adapted for, incorporated into, or used by, more than one drug sharing common structural elements; and

  3. facilitates the manufacture or development of more than one drug through a standardized production or manufacturing process or processes.

It is FDA's responsibility to determine if a technology qualifies as a platform technology before it can be designated as a designated platform technology. To support a designation, the (preliminary evidence) information must sufficiently demonstrate that the platform technology can be incorporated into, or used by, the drug(s) under investigation without adversely affecting quality, manufacturing, or safety.

Potential Benefits of a Platform Technology Designation

  • Engaging in early interactions with FDA

  • Receiving timely advice

  • Leveraging data from a prior product that used the designated platform technology

  • Leveraging certain nonclinical safety data

  • Considering previous inspectional findings by FDA for subsequent marketing applications

You can view the full draft guidance by clicking here for more detailed information.


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