The FDA Law Blog

NOVEMBER 1, 2022

FDA/CBER (the Agency) provided an overview of CMC challenges for CART development (e.g., Use of automation does not allow for bypassing FDA requirements with respect to method transfer comparability. Opportunity for feedback from FDA if provided pre-BLA. Release testing alone is not sufficient.

FDA 59

FDA Process Improvement 59

ISPE

MARCH 29, 2023

Application of this innovative approach will quickly orient regulators to the content of Module 3, “present product quality benefit-risk considerations, summarize the pharmaceutical development, present an overall understanding of the product quality,” 1 and facilitate continuous improvement.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MARCH 29, 2023

Application of this innovative approach will quickly orient regulators to the content of Module 3, “present product quality benefit-risk considerations, summarize the pharmaceutical development, present an overall understanding of the product quality,” 1 and facilitate continuous improvement.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

AUGUST 29, 2022

Following approval of an initial marketing application, postapproval changes are needed to ensure adequate supply, mitigate supply risk, expand patient market access, optimize manufacturing processes, improve analytical methods, and comply with new regulatory expectations. Accumulus Synergy White Paper. 2021.09.046.

Documentation 52

Documentation FDA Communication Packaging 52

ISPE

SEPTEMBER 11, 2023

FDA Official Warns Manufacturers of Common Problems Found in Aseptic Operations.” www.raps.org/news-and-articles/news-articles/2023/3/fda-official-warns-manufacturers-of-common-problem 25 US Food and Drug Administration Center for Drug Evaluation and Research. September 2022. 25%20from%202022%20to%202027 24 Eglovitch, J. 7 March 2023.

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52