FDA Issues Final Guidance on Formal Meetings with Drug and Biologic Product Sponsors

The Food and Drug Administration (FDA) has announced the availability of a final guidance document for industry titled 'Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products.' This guidance outlines recommendations for formal meetings between the FDA and sponsors or applicants involved in the development and review of new drug or biological products regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). The guidance finalizes a draft issued in September 2023.