What Do You Think Was The Single Most Consequential Event Or Result In Pharma/Biopharma In 2023?
J
Jared Schuster
M
Muctarr Sesay, Ph.D.
J
Jean-Chrisophe Hyvert
M
Minjee Kim
F
Francisco Heredia
In 2023, the FDA released the draft guidance titled: “Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products.” This draft guidance provides insight into the FDA’s expectations for cell and gene therapy (CGT) developers regarding manufa...
What Do You See As The Most Significant Regulatory Decision Or Guidance On The Horizon For 2024 (Or Beyond)?
J
Jean-Christophe Hyvert
R
Robert Nass
R
Rose Blackburne, M.D., MBA
W
Woosang Lee
A
Andreas Nordheider, Ph.D.
The revision of EU GMP Annex 1, Manufacture of Sterile Medicinal Products, became effective in August 2023. This regulatory document provides general guidance for the manufacture of all sterile products using the principles of Quality Risk Management (QRM), to ensu...