On May 29, 2024, the U.S. Food and Drug Administration (“FDA”) released draft guidance titled Platform Technology Designation Program for Drug Development. The draft guidance describes the process for requesting and receiving a “platform technology designation,” which could provide an expedited pathway for FDA review of drugs or biologics that utilize that platform technology. The platform technology designation program was established under Section 506K of the Federal Food, Drug, and Cosmetic Act.
The FDA lists four potential candidates that could qualify for platform status: (1) lipid nanoparticle (“LNP”) platforms for mRNA vaccine or gene therapy products, (2) monoclonal antibody platform technologies, (3) platforms using a chemically defined targeting moiety in conjugation with a well-characterized synthetic siRNA, and (4) LNP platforms encapsulating different short, single-stranded or double-stranded oligonucleotides. The FDA also notes examples of technologies that could be “inappropriate” for the new pathway. Those technologies include established formulation technologies that have been traditionally used for immediate release and extended-release solid oral dosage forms (e.g., matrix, osmotic pump), established formulation technologies for oral and parenteral dosage forms, and other drug delivery systems, as well as device delivery technologies (e.g., syringe, autoinjector). The FDA notes that such device delivery technologies generally are not essential to the structure or function of the drug or biological product and not expected to facilitate the manufacture or development of the drug. Interested stakeholders may submit comments to the FDA on the draft guidance until July 29, 2024.
WilmerHale has extensive experience in connection with intellectual property, FDA, and regulatory matters involving platform technologies and their utilization in drugs or biologics. Please reach out to the contacts below with any questions.
