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

European Pharmaceutical Review

NOVEMBER 9, 2023

Following her presentation on age-related disease at BioFuture 2023, Executive Vice President of Drug Development for MyMD Pharmaceuticals ® , Jenna Brager, shares with EPR why the company’s next-generation tumour necrosis factor (TNF)-alpha inhibitor has potential in inflammatory and autoimmune disorders.

Pharmaceutical Companies 106

Pharmaceutical Companies Pharmaceutical Companies Immunization Process Improvement 106

European Pharmaceutical Review

DECEMBER 1, 2023

This is also evident from the number of US Food and Drug Administration (FDA) approvals and European Medicines Agency (EMA) approvals, which still show a large number of approvals on the small molecule side. I think we are increasingly seeing the focus move to globally approvable drug substances or drug products.

Dosage 85

Dosage Process Improvement FDA 85

ISPE

SEPTEMBER 11, 2023

This article presents relevant insights on the current regulatory and technical landscape for decentralized manufacturing, with select examples of current applications, and discusses perspectives on evolving and adapting the current regulations to meet future capabilities. September 2022. 25%20from%202022%20to%202027 24 Eglovitch, J.

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 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. Section 3.2.S.2.6

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. Section 3.2.S.2.6

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

AUGUST 30, 2022

In addition, single-use technologies have been increasingly employed throughout manufacturing because of the advantages they offer, including reductions in cost, manufacturing footprint, contamination risk, and processing times (Figure 1). There is undoubtedly a need for improved supply chain flexibility to address shortages.

Documentation 52

Documentation FDA Packaging Communication 52