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Home » Combination Product Manufacturers Must Be ‘Bilingual’ When It Comes to Regulations
Combination Product Manufacturers Must Be ‘Bilingual’ When It Comes to Regulations
Whether a company is primarily a drug manufacturer or a device manufacturer, if it starts making combination products, it will have new additions to its quality management system (QMS) and will “need to learn to speak the language for both sides of the combination product,” according to a former FDA official.