Nonclinical data supporting the pharmacology and toxicology of the drug, data on the drug's chemistry, manufacturing, and controls (CMC), and clinical safety and efficacy data from phase I through phase III programs are synthesized into one cohesive application describing the safety and efficacy profile of the drug in a given patient population. 1 In the European Union, the data package submitted to the European Medicines Agency (EMA) to support a marketing approval is called a Marketing Authorisation Application (MAA). In the United States, the data package submitted to the US Food and Drug Administration (FDA) to support a marketing approval is called either a New Drug Application (NDA) for small‐molecule drugs, or a Biologics License Application (BLA) for large‐molecule drugs (biologics). In this tutorial, we discuss a range of programs implemented by global Health Authorities to expedite both drug development and Health Authority review of marketing applications. Once clinical trials have been initiated, generating the breadth and depth of data required to appropriately assess the benefit/risk of a new drug takes years of effort across multiple disciplines.
In our previous tutorial, we discussed the data required to initiate first‐in‐human clinical trials.
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