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N P M A L I B R A RY U P D ATE TRAINING REQUIREMENTS FOR THE REVISED HAZARD COMMUNICATION Standard-compliant Deadline: December 1, 2013, J U LY / A U G 2013The Occupational Safety and Health Administration
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NPMA stands for New Drug Application. It is a submission to the Food and Drug Administration (FDA) for a new pharmaceutical drug.
Any pharmaceutical company seeking approval to market a new drug in the United States is required to file an NDA.
The NDA must include comprehensive data on the drug's safety and efficacy, manufacturing processes, labeling, and proposed usage.
The purpose of the NDA is to demonstrate to the FDA that the new drug is safe and effective for its intended use.
Information such as preclinical and clinical data, chemistry and manufacturing details, and proposed labeling must be reported on the NDA.
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