Accordingly, the FDA aims to review supplemental applications within a total of 10 months. For a subsequent marketing application for additional use of an approved drug, the appropriate nonclinical and CMC data may have already been reviewed by the Agency in the initial application as a result, supplemental marketing applications typically contain less data. Once a drug is initially approved to treat a specific population or indication, applicants may conduct additional clinical studies to support subsequent FDA approvals in other settings (e.g., in another line of therapy), in combination with other treatments, or in other diseases. Once these data are generated, Health Authorities require time to evaluate whether the data provided support a marketing approval.įor a new drug, the FDA commits to reviewing most NDAs/BLAs within a total of 12 months. 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.
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. Archives
January 2023
Categories |