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

AUGUST 3, 2023

With the corrective and preventive action (CAPA) process often a “one-size-fits-all” approach, a whitepaper by the Medical Device Innovation Consortium (MDIC) Case for Quality Collaborative Community (CfQcc) has instead shared a risk-based framework focusing on continuous improvement. These results are included in most recent paper.

Documentation 52

Documentation Process Improvement FDA 52

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

Pharma Marketing Network

JANUARY 9, 2025

FDA and EMA Updates: Regularly monitor guidelines from agencies like the FDA (U.S.) Technologies like AI, big data, and AR/VR streamline processes, improve targeting, and create more engaging campaigns. Navigating the legal landscape requires agility and foresight, especially when new regulations surface.

HIPAA 52

HIPAA Process Improvement FDA Communication 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.

Process Improvement 98

Process Improvement Packaging Compounding Dosage 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.

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