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The Integrated Review: FDA Modernizes the Review of New Drug Marketing Applications

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A Correction to this article was published on 16 December 2020

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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.

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References

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Acknowledgements

The authors thank Ellen Wertheimer, MHS, and J. Rick Turner, PhD, DSc, DRT Strategies Inc, for medical writing assistance.

Funding

None reported.

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Authors and Affiliations

  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

    Rhonda M. Hearns-Stewart MD

  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

    John Farley MD

  3. Office of New Drug Policy, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA

    Kerry Jo Lee MD

  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

    Sarah Connelly MD

  5. Division of Anesthesiology, Addiction Medicine and Pain Medicine, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA

    Naomi Lowy MD

  6. Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA

    Peter Stein MD

  7. Special Programs, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA

    Kevin Bugin MS, PhDc, RAC

Authors
  1. Rhonda M. Hearns-Stewart MD
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  2. John Farley MD
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  3. Kerry Jo Lee MD
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  4. Sarah Connelly MD
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  5. Naomi Lowy MD
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  6. Peter Stein MD
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  7. Kevin Bugin MS, PhDc, RAC
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Contributions

All authors contributed to this manuscript in the following ways: substantial contributions to the conception or design of the work, or the acquisition, analysis, or interpretation of data for the work; drafting the work or revising it critically for important intellectual content; and final approval of the version to be published. They have also agreed to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Corresponding author

Correspondence to Rhonda M. Hearns-Stewart MD.

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This article reflects the views of the authors and should not be construed to represent FDA’s views or policies.

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Hearns-Stewart, R.M., Farley, J., Lee, K.J. et al. The Integrated Review: FDA Modernizes the Review of New Drug Marketing Applications. Ther Innov Regul Sci 55, 467–472 (2021). https://doi.org/10.1007/s43441-020-00240-1

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  • DOI: https://doi.org/10.1007/s43441-020-00240-1

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