Designating a Platform Technology: FDA's Long-Awaited Draft Guidance | Insights & Resources | Goodwin – Goodwin Procter

In newly released Draft Guidance from the U.S. Food and Drug Administration (FDA) entitled, Platform Technology Designation Program for Drug Development, the FDA addresses its new designation program for platform technologies, which is intended to bring efficiencies to drug development, manufacturing, and review processes for applications that incorporate designated platform technologies.
FDA notes that the definition of a “platform” in this context may differ from how the term is used in the industry, so it clarifies that under the statute, a “platform” is defined as a well-understood and reproducible technology where it: (1) is incorporated in or utilized by a drug or biologic and is essential to the structure or function of such drug or biologic; (2) can be adapted for, incorporated into, or utilized by, more than one drug or biologic sharing common structural elements; and (3) facilitates the manufacture or development of more than one drug or biologic through a standardized production or manufacturing process or processes. Criteria for designation as outlined by statute are as follows: (1) it is incorporated in, or used by, an approved drug or biologic; (2) preliminary evidence demonstrates that the platform technology has the potential to be incorporated in, or used by, more than one drug or biologic without an adverse effect on quality, manufacturing, or safety; and (3) data or information indicates that incorporation or use of the platform technology has a reasonable likelihood to bring significant efficiencies to the product development or manufacturing process and to the review process. FDA identifies the following examples of potential platform technologies: lipid nanoparticle (LNP) platforms for mRNA vaccine or gene therapy products; monoclonal antibody platform technologies; platforms using a chemically defined targeting moiety in conjugation with a well-characterized synthetic siRNA; and LNP platforms encapsulating different short, single stranded or double stranded oligonucleotides.
Importantly, the FDA outlines the following for industry:
FDA clarifies that:
Finally, FDA notes that potential benefits for sponsors receiving platform technology designation include the following:
Interested stakeholders may submit comments to the FDA on the Draft Guidance to Docket FDA-2024-D-1829 until July 29, 2024. Please contact any of the authors or your Goodwin attorney with any questions or if you would like to submit a comment.
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