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.

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Documentation Process Improvement FDA 52

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.

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FDA Process Improvement 59

European Pharmaceutical Review

MAY 29, 2023

Recently, the European Medicines Agency (EMA) took the lead in pushing for process improvements using technologies already established in other manufacturing sectors. Despite this, only 13 nanomedicines had been approved by the US Food and Drug Administration (FDA) before 2015. Yet in 2021, 100 nanomedicines had been marketed.

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Process Improvement Packaging Vaccines FDA 69

European Pharmaceutical Review

NOVEMBER 9, 2023

MyMD plans to present the data to the US Food and Drug Administration (FDA) and intends to advance the clinical programme for MYMD-1 into Phase III either alone or through partnership. There are no FDA-approved medications to treat sarcopenia. Why is a TNF-α inhibitor promising as a first-in-class therapeutic for sarcopenia/frailty?

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Pharmaceutical Companies Pharmaceutical Companies Immunization Process Improvement 102

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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Dosage Process Improvement FDA 81

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.

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Health and Personal Care Stores Vaccines Packaging Documentation 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. Pharmaceutical Engineering 41, no. Draft Guidance for Industry.

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Documentation FDA Communication Packaging 52