FDA Drafts Guidance To Spur Uptake In Continuous Manufacturing
FDA is hoping that by laying out its expectations for continuous manufacturing, applicants will feel more comfortable about adopting such approaches instead of sticking with conventional batch methods.
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FDA is joining the government’s bioresponse and defense efforts to develop small, mobile, on-demand manufacturing systems as next-tech solutions to dwindling domestic supply sources for essential drugs.
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.
A recent survey shows that pharmaceutical manufacturers are increasingly interested in adopting continuous manufacturing. Most respondents say they plan to use this mode of manufacturing for their new drugs.