FDA Presentation Process Improvement 
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.
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.
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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
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
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.
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.
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.
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