The US Food and Drug Administration (FDA) has published a much-awaited draft guidance detailing how it plans to implement its new platform technology designation program. Drug sponsors can use platform technologies to manufacture more than one drug or biological product through a standardized production or manufacturing process, and the program is intended to provide predictability on how they are reviewed.
The FDA had already allowed the technology when it approved Vertex Pharmaceuticals and CRISPR Therapeutics Casgevy, a gene editing treatment for sickle cell disease, late last year. However, under section 506K of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which was updated as part of the 2022 Prepare for and Respond to Existing Viruses, Emerging New Threats (PREVENT) Pandemics Act, the agency was required to publish a draft guidance by the start of the year. The agency said program should lead to efficiencies when reviewing drugs and biological products that use designated platform technologies…
