The guidance provides recommendations for those interested in participating in FDA’s Advanced Manufacturing Technologies Designation Program. FDA published a final guidance on Jan. 2, 2025 for those ...

Kelley Burridge, PhD, Product Quality Team Leader, OBP, OPQ, CDER, U.S. FDA, discusses how advanced manufacturing technology can improve things such as cost and efficiency. In part of the session ...

New facilities are expected to focus on manufacturing next-generation medicines and biologic medicines. Eli Lilly and Johnson & Johnson (J&J) have both announced major investments in advanced drug ...

Now more than ever, there is a growing awareness of the fragility of global supply chains. For pharmaceuticals production – an industry that has become increasingly globalized over the past few ...

A surge in US Food and Drug Administration (FDA) rejections and delays has highlighted chemical, manufacturing and controls (CMC) as a major barrier to approval in cell and gene therapy development.