The Integrated Review: FDA Modernizes the Review of New Drug Marketing Applications
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ANALYTICAL REPORT
The Integrated Review: FDA Modernizes the Review of New Drug Marketing Applications Rhonda M. Hearns‑Stewart, MD1 · John Farley, MD2 · Kerry Jo Lee, MD3 · Sarah Connelly, MD4 · Naomi Lowy, MD5 · Peter Stein, MD6 · Kevin Bugin, MS, PhDc, RAC7 Received: 5 October 2020 / Accepted: 29 October 2020 © The Drug Information Association, Inc 2020
Abstract New Drug Applications and Biologics Licensing Applications submitted to the US Food and Drug Administration (FDA) are reviewed by an interdisciplinary team of regulatory scientists that includes medical officers, clinical pharmacologists, toxicologists, statisticians, and drug labeling experts. Upon review of an applicant’s submitted evidence from nonclinical studies, clinical trials, and manufacturing capabilities, the review team evaluates the benefits and risks of the drug and makes a scientifically-informed decision. As part of a multi-year, multi-phase New Drugs Regulatory Program Modernization effort, the FDA has recently redesigned how it reviews and documents its decisions with regard to marketing applications. This article describes the origins and rationale of the new Integrated Assessment process and Integrated Review document, summarizes how these differ from the FDA’s traditional review of marketing applications, and discusses what industry can expect from a modernized drug review. Keywords Drug regulation · Drug approval · Drug evaluation · Industry · Marketing · United States Food and Drug Administration
Introduction The mission of the U.S. Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research (CDER, the Center) is to protect and promote public health by Disclaimer This article reflects the views of the authors and should not be construed to represent FDA’s views or policies. * Rhonda M. Hearns‑Stewart rhonda.hearns‑[email protected] 1
Integrated Review of Marketing Applications, Office of New Drugs Special Programs, Center for Drug Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA
2
Director, Office of Infectious Disease, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA
3
Office of New Drug Policy, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA
4
Office of Infectious Disease, Division of Antivirals, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA
helping to ensure that human drugs are safe and effective for their intended use, that they meet established quality standards, and that they are available to patients. The FDA’s regulatory decisions related to new drugs facilitate access to treatments that save and improve lives. These decisions also signal potential approvability to other regulatory agencies. Therefore, it is important for the FDA to clearly document and make publically available the rationale for its decisions. 5
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