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New Drugs Regulatory Program Modernization: Integrated Assessment of Marketing Applications and Integrated Review Documentation

Request for Comments

Overview

The Integrated Assessment of Marketing Applications, developed as part of the New Drugs Regulatory Program (NDRP) Modernization, includes an updated process and review template for the assessment and documentation of new drug product marketing applications [i.e., new drug applications (NDAs) or biologics license applications (BLAs)] in the Center for Drug Evaluation and Research (CDER). The resultant Integrated Review documentation is the product of an interdisciplinary team assessment process that provides collaborative discussions of key review issues that span multiple disciplines and includes resolution of important issues pertinent to benefit-risk assessments.

This interdisciplinary approach facilitates clarity of decision making and ensures input from relevant disciplines in the consideration of scientific issues. FDA believes the format and content of the Integrated Review documentation will provide sufficient detail concerning the evidence of efficacy and assessment of risk and risk management as well as a clearer description of FDA's analysis of the scientific issues raised by the application and the scientific reasoning supporting the benefit-risk determination. The overall objective is to more effectively communicate the basis for FDA’s decision on applications.

This Integrated Review document replaces the previous documentation, which included a separate review document authored by each discipline. It also replaces the multidisciplinary review (i.e., Unireview) in which each discipline provided a separate review section but within a single review document. FDA implemented the Integrated Review documentation for new molecular entities, original BLAs, and select efficacy supplements. FDA plans to expand the scope to other marketing application types in the near future.

The Integrated Review documentation template has three main components:

Executive Summary:

  • Represents FDA’s conclusions regarding key scientific and regulatory issues while describing any differences of scientific opinion or perspective.
  • Provides a summary of FDA's decision and assessment of the application, including FDA's benefit-risk determination (as currently employed in marketing application reviews).
  • Provides an overall Agency assessment, including an overview of the major decisions made during the review process, and a brief discussion of the basis for the decisions.

Interdisciplinary Assessment:

  • Includes succinct, integrated, focused analyses of the evidence of benefit, risk and risk management, and therapeutic individualization (e.g., special populations, drug interactions).
  • Highlights key review issues (including analyses specific to key issues) the review team thinks are pertinent to the decision-making process. Issues are presented and assessed in an interdisciplinary manner.
  • Includes any dissenting data interpretations.

Additional Analyses and Information:

  • Contains assessments and analyses that are supportive and/or important to key facts/data or conclusions included in the overall review, and in certain instances may include discipline-specific content/appendices (e.g., relevant pharmacology/toxicology information).
  • May contain work that did not directly impact the overall assessment of benefit-risk, regulatory action, labeling, or risk-mitigation plans.
  • Includes separate reviews of reviewers who disagree with significant elements of the Executive Summary and Interdisciplinary Assessment sections or the decision of the Signatory Authority.

In general, the first two parts of the Integrated Review document would be expected to provide a complete explanation of FDA's action and supporting analyses, with the third component (the “Additional Analyses and Information” section) providing additional detail on the comprehensive analyses FDA conducted in its review of the drug application.

Comments

As part of FDA's ongoing evaluation of the Integrated Review documentation, the Agency is interested in receiving responses to the following questions/topics, in addition to any general comments the public might have. We emphasize that the focus of this request is to seek input that prioritizes feedback specifically on characteristics of the Integrated Review document. For convenience, it would be helpful if commenters refer to the numbered topic and question when submitting responses and comments to the following topics and/or questions:

  1. We are interested in preserving for stakeholders what they find most useful in FDA reviews.
    1. Comparing the Integrated Review to previous reviews, is there any information you are having difficulty locating?
    2. Are you able to use the Integrated Review for the same purpose that you used previous reviews? If not, please provide specific examples.
  2. We are interested in specific recommendations about any areas of the Integrated Review documentation of the Integrated Assessment that can be improved to meet the needs of stakeholders.
  3. We are interested in stakeholders' views regarding the advantages and disadvantages of an interdisciplinary assessment presentation of key review issues and the resultant integration of the assessments of multiple disciplines into a single Integrated Review document.
  4. We would like to know whether the new format of the Integrated Review documentation for the Integrated Assessment provides clarity of benefit-risk assessments and informs your knowledge of FDA's basis for making decisions.
  5. Based on the integrated review, were the issues that concerned the review team clear and understandable? If so, what helped achieve this? If not, what can be improved?

You may submit electronic comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before 90 days after date of publication in the Federal Register. The regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of 90 days after date of publication in the Federal Register.

Federal Register Notice

Comments may also be submitted on the public docket.

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