This labelling standard describes the requirements necessary to receive market authorization (a Drug Identification Number (DIN)) for non-prescription oral antitussive products...
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This document provides guidance to vaccine manufacturers seeking authorization for their vaccine that targets the SARS-CoV-2 virus. This guidance applies to applications under...
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The Fixed Point Surveillance (FPS) network monitors public radiation dose due to radioactive materials in the atmosphere. The FPS network is used primarily to measure the...
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This document is intended to provide guidance with respect to the Quality (Chemistry and Manufacturing) portion of Applications for Drug Identification Numbers (DINAs) for...
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