FDA's Much Anticipated New Cell and Gene Therapy Guidance Outlines a Conservative Approach to Manufacturing Changes | King & Spalding
Biologics have long been defined by their processes, raising complicated questions about how to assess the effect of manufacturing changes on product quality—i.e., whether pre- and...
Peter Marks Jonathand Grinstein Drug Administration King Spalding Gene Therapy Regulation To Device Center Agency Center
Source: jdsupra.com