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Glossary

Critical Quality Attribute (CQA)

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A physical, chemical, biological or microbiological property or characteristic that should be within an appropriate limit, range, or distribution to ensure the desired product quality.

 

Other glossary definitions

C

Clinical Trial Application (CTA)

The conduct of clinical trials is subject to prior authorization from health authorities, to ensure…

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D

De Novo

The US Food and Drug Administration (FDA) automatically classifies Class I or II medical devices…

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