- October 30, 2020
New Drugs Regulatory Program Modernization: Implementation of the Integrated Assessment of Marketing Applications and Integrated Review Documentation
- Meeting Recording
- Requests for Oral Presentations
- Meeting Information
- Meeting Materials
The Food and Drug Administration (FDA) is announcing a public workshop entitled “New Drugs Regulatory Program Modernization: Implementation of the Integrated Assessment of Marketing Applications and Integrated Review Documentation.” The Integrated Assessment of Marketing Applications, developed as part of the New Drugs Regulatory Program Modernization, includes a new 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 new Integrated Review document replaces the current 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 is currently undergoing a phased implementation of 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 new 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.
- Discipline-Specific Appendices:
- 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 (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 appendices) providing additional detail on the comprehensive analyses FDA conducted in its review of the drug application.
Please use the following link to access the meeting recording. https://www.youtube.com/watch?v=P3ybCCVIfqQ.
As part of FDA's ongoing evaluation of the Integrated Assessment and its implementation, 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 meeting 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:
- We are interested in preserving for stakeholders what they find most useful in FDA reviews.
- Comparing the Integrated Review to previous reviews, is there any information you are having difficulty locating?
- Are you able to use the Integrated Review for the same purpose that you used previous reviews? If not, please provide specific examples.
- 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.
- 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.
- 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.
You may submit electronic comments related to each of the above topics/questions during online registration and/or via email to: ONDPublicMTGSupport@fda.hhs.gov. Please refer to the Federal Register Notice for additional information regarding submitting electronic comments to the docket.
Please also see the Federal Register Notice for information regarding submitting paper/written comments.
To be considered for the workshop, comments must be received by the close of registration on September 30, 2020 by 11:59 PM (ET). However, the comment period will remain open following the workshop until December 30, 2020.
The resulting discussions from the meeting, paper/written submissions, and electronic comments received will be taken into consideration.
FEDERAL REGISTER NOTICE
Federal Register Notice FDA–2020–N–1550 is accessible here. Comments may also be submitted on the public docket
During online registration, you may indicate if you wish to present during a public comment session or participate in a specific session, and which topic(s) you wish to address. We will do our best to accommodate requests to make public comments. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations, and request time for a joint presentation, or submit requests for designated representatives to participate in the focused sessions. All requests to make oral presentations must be received by the close of registration on September 30, 2020 by 11:59 PM (ET). Following the close of registration, we will determine the amount of time allotted to each presenter and the approximate time each oral presentation is to begin and will select and notify participants by October 14, 2020.
If selected for presentation, you must submit electronic copies of any presentation materials (Power Point or PDF) to ONDPublicMTGSupport@fda.hhs.gov no later than October 21, 2020. No commercial or promotional material will be permitted to be presented or distributed at the public workshop.
The public workshop will be held by webcast only. It will take place virtually on October 30, 2020 from 9:00 AM to 3:00 PM (ET). Note that although this public workshop is scheduled from 9:00 AM to 3:00 PM, it may be extended or may end early depending on the level of public participation.
Registration to attend this virtual meeting and other information can be found at: https://www.eventbrite.com/e/integrated-assessment-of-marketing-applications-workshop-tickets-102979608782. Persons interested in attending this virtual public workshop must register by September 30, 2020 by 11:59 PM (ET).
The link to the webcast will be provided the week of the meeting.
If you have never attended a Connect Pro event before, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm.
To get a quick overview of the Connect Pro program, visit https://www.adobe.com/go/connectpro_overview. FDA has verified the website addresses in this webpage as of the date this webpage publishes, but websites are subject to change over time.
|Summary||(PDF - 215 KB)|
|FDA Public Workshop (Full Transcript)||(PDF - 1 MB)|
|Agenda||(PDF - 1 MB)|
|Rukobia Integrated Review Document||(PDF - 14 MB)|
|Tauvid Integrated Review Document||(PDF - 12 MB)|
|Public Workshop Slides - Morning Session incl. Introduction to the Integrated Assessment||(PDF - 1.07 MB)|
|Public Workshop Slides - Midday Session incl. External Stakeholder Presentations||(PDF - 4.09 MB)|
|Public Workshop Slides - Afternoon Session incl. FDA Panel, Concluding Remarks, and What's Next||(PDF - 887 KB|
If you need special accommodations due to a disability and/or need more information regarding this meeting, please contact the Public Meeting Team no later than October 16, 2020 via email at ONDPublicMTGSupport@fda.hhs.gov.
|Workshop on FDA Implementation of the Integrated Assessment of Marketing Applications and Integrated Review Documentation||pdf (215.40 KB)|