ABSTRACT
The documentation required in an application for marketing approval of a new drug is intended to accurately present the drug’s whole story, including what happened during the clinical tests; how the drug is formulated (its components and composition); results of animal studies; how the drug behaves in the human body; and how it is synthesized, processed, manufactured, and packaged. The Food and Drug Administration (FDA) requires samples of the drug that represent the different levels of dosage available to the public, along with associated labeling. Full reports of a drug’s studies must be submitted so that the FDA can evaluate the data. The review team at the Agency-chemists, pharmacologists, physicians, pharmacokineticists, statisticians, and microbiologistsneed access to this information in order to evaluate the safety, efficacy, benefits, and risks of the drug in order to complete the approval process.
