Today Kim Benton, DHC's Master Principal and Head of Regulatory, published a guest column with Cell & Gene via Life Science Connect on what FDA's draft platform guidance might mean for CGT companies.
"The U.S. FDA released the much-anticipated draft guidance Platform Technology Designation Program for Drug Development1 on May 28, 2024. This guidance was issued to establish a program for designation of platform technologies as required by the PREVENT Pandemics Act2 and provides information on how FDA intends to implement the program. Comments may be submitted to the public docket3 until July 29, 2024.
When federal statutes and FDA guidances introduce new designations and programs, a slate of questions come to mind for product developers, including: What is this? Is my product/technology eligible? How would this benefit me? How do I get this designation? Let’s consider these questions from the perspective of cell and gene therapy products and technologies used in their manufacture."
...continue reading the article here.
