Lexology June 11, 2024
Taking a step toward fulfilling its requirements under Section 506K of the Federal Food, Drug, and Cosmetic Act (Section 506K), FDA has issued Draft Guidance describing how the agency intends to implement the Platform Technology Designation Program. Section 506K was established by Section 2503 of the Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act of 2022 and enacted as part of the 2023 Consolidated Appropriations Act.
Per Section 506K (as well as the draft guidance):
A platform technology is a well-understood and reproducible technology, such as a nucleic acid sequence or delivery method, that (1) is essential to a drug, (2) can be adapted for or otherwise used by multiple drugs that share common structural...
Today's Sponsors
Today's Sponsor