Author name: development

Cell and gene therapy (CGT) products are gradually paving the path to provide novel treatment options for patients that have complex conditions related to cancers, genetic disorders, and other chronic conditions. However, CGT products are also associated with barriers related to cost that could significantly affect or delay patient access to these life-changing therapies. Indeed, […]

After a biosimilar or interchangeable product gets regulatory approval by the USFDA, manufacturers often need to adjust their manufacturing processes. These changes after approval are essential for keeping product consistency, enhancing processes, or tackling operational issues. However, because biologics are complex, even small modifications can significantly affect the product’s safety, efficacy, and quality. As a

In the past four decades, the number of drugs being approved by the FDA has increased significantly. Interestingly, while the number of products has only increased, the time taken by the FDA to review and eventually market them has steadily decreased. A recent article by Seoane-Vazquez and team shows that while the median time to