A discussion paper from the US Food and Drug Administration poses 20 questions to stakeholders for early input in 11 areas of consideration on its plans to develop a regulatory framework for distributed drug manufacturing, including manufacturing at the point of care.
Twenty Questions: How Should The US FDA Regulate Distributed Drug Manufacturing?
What happens when manufacturing plants are moving targets? When quality systems are at once more centralized and dispersed? When plant operators are health care workers? Agency wants input before settling on the answers.
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