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It is well known that, the Food and Drug Administration (FDA) has been working to implement the transition of biological products which are currently approved as drug products and are ‘deemed to be licensed’ as biologics under the Public Health Service Act on March 23, 2020.
Finished drug products contain minute amount of impurities which find their way into drugs at various junctures of manufacturing. They can be residual catalysts from synthesis or might get picked when in contact with manufacturing equipment, containers or other sources.
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