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. There is definitely an interest in advanced therapies, such as cell and gene therapy, plasmids, mRNA, and viral vectors.

Dosage 98

Dosage Process Improvement FDA 98

ISPE

SEPTEMBER 11, 2023

Although the novelty of these modes of manufacturing has led to some definitional ambiguities, initial working definitions and terminology have been drafted by several regulators, trade organizations, and subject matter experts. FDA Official Warns Manufacturers of Common Problems Found in Aseptic Operations.” September 2022.

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. Pharmaceutical Engineering 42, no.

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. Pharmaceutical Engineering 42, no.

Documentation 52

Documentation Dosage Packaging Communication 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 Draft Guidance for Industry.

Documentation 52

Documentation FDA Communication Packaging 52