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 57

FDA Process Improvement 57

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 115

Pharmaceutical Companies Pharmaceutical Companies Immunization Process Improvement 115

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 98

Dosage Process Improvement FDA 98

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

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

OCTOBER 27, 2022

Since 2016, drug approvals per clinical campaign have outpaced the average across all modalities, resulting in 11 FDA-approved therapies in that span. Combining the incremental process improvements previously mentioned results in an optimized facility, with the adjusted block flow shown in Figure 5. Conclusion.

Process Improvement 98

Process Improvement Packaging Compounding Dosage 98