What Do You Think Was The Single Most Consequential Event Or Result In Pharma/Biopharma In 2023?

PHARMA’S ALMANAC: In 2023, the FDA released the draft guidance titled: “Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products.” This draft guidance provides insight into the FDA’s expectations for cell and gene therapy (CGT) developers regarding manufacturing changes and comparability assessments under chemistry, manufacturing, and control (CMC) requirements.