FDA Continuous Manufacturing Guidance Raises Concerns About Scope And Cost
Makers of brand pharmaceuticals focused on scope issues and the definition of terms in their comments on the US FDA's draft continuous manufacturing guidance, while makers of generic drugs raised concerns about cost and lack of benefit.
You may also be interested in...
US FDA Sees Slow But Steady Progress In Adoption Of Continuous Manufacturing
The COVID-19 pandemic has prompted the ICH to delay by six months its efforts to develop Q13 guideline on continuous manufacturing, now not expected until May 2022.
New CDER Lab Will Help Push Advanced Manufacturing Adoption
US FDA plans to open a manufacturing research lab near its White Oak headquarters in 2021 to facilitate evaluation of novel manufacturing technology.
Industry Not Sold On FDA Emerging Technology Program
FDA’s calls for more generic industry participation in its Emerging Technology Program fell on deaf ears at a recent meeting, with several complaining about the costs and value of investing in new manufacturing technologies.