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.
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If the US FDA could track production, it could anticipate shortages – and national security threats from countries like China.
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.
How should FDA make sure new safety information gets widely disseminated – especially against a history of many communications that have not shown the sustained ability to reach the most active prescribers? The agency got an earful of suggestions from the most recent safety review of the asthma/allergy drug montelukast.