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`EXHIBIT 11
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`EXHIBIT 11
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`PDUFA REAUTHORIZATION PERFORMANCE
`GOALS AND PROCEDURES FISCAL YEARS 2018
`THROUGH 2022
`
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`
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`I. ENSURING THE EFFECTIVENESS OF THE HUMAN DRUG REVIEW
`PROGRAM
`A. Review Performance Goals
`B. Program For Enhanced Review Transparency And Communication For NME
`NDAs And Original BLAs
`C. First Cycle Review Management
`D. Review Of Proprietary Names To Reduce Medication Errors
`E. Major Dispute Resolution
`F. Clinical Holds
`G. Special Protocol Question Assessment And Agreement
`H. Meeting Management Goals
`I. Enhancing Regulatory Science And Expediting Drug Development
`J. Enhancing Regulatory Decision Tools To Support Drug Development And
`Review
`K. Enhancement And Modernization Of The FDA Drug Safety System
`
`
`
`II. ENHANCING MANAGEMENT OF USER FEE RESOURCES
`A. Resource Capacity Planning And Modernized Time Reporting
`B. Financial Transparency And Efficiency
`
`
`III. IMPROVING FDA HIRING AND RETENTION OF REVIEW STAFF
`A. Completion Of Modernization Of The Hiring System Infrastructure And
`Augmentation Of System Capacity
`B. Augmentation Of Hiring Staff Capacity And Capability
`C. Complete Establishment Of A Dedicated Function To Ensure Needed Scientific
`Staffing For Medical Product Review
`D. Set Clear Goals For Drug Review Program Hiring
`E. Comprehensive And Continuous Assessment Of Hiring And Retention
`
`
`IV. INFORMATION TECHNOLOGY GOALS
`A. Objective
`B. Improve The Predictability And Consistency Of PDUFA Electronic Submission
`Processes
`C. Enhance Transparency And Accountability Of FDA Electronic Submission And
`Data Standards Activities
`
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`V. IMPROVING FDA PERFORMANCE MANAGEMENT
`
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`VI. PROGRESS REPORTING FOR PDUFA VI AND CONTINUING PDUFA V
`VI. PROGRESS REPORTING FOR PDUFA VI AND CONTINUING PDUFA V
`INITIATIVES
`INITIATIVES
`
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`VII. DEFINITIONS AND EXPLANATION OF TERMS
`VII. DEFINITIONS AND EXPLANATION OF TERMS
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`PDUFA REAUTHORIZATION PERFORMANCE
`GOALS AND PROCEDURES FISCAL YEARS 2018
`THROUGH 2022
`This document contains the performance goals and procedures for the Prescription Drug User
`Fee Act (PDUFA) reauthorization for fiscal years (FYs) 2018-2022, known as PDUFA VI. It is
`commonly referred to as the “goals letter” or “commitment letter.” The goals letter represents
`the product of FDA’s discussions with the regulated industry and public stakeholders, as
`mandated by Congress. The performance and procedural goals and other commitments specified
`in this letter apply to aspects of the human drug review program that are important for facilitating
`timely access to safe, effective, and innovative new medicines for patients. While much of
`FDA’s work is associated with formal tracked performance goals, the Agency and industry
`mutually agree that it is appropriate to manage some areas of the human drug review program
`with internally tracked timeframes. This provides FDA the flexibility needed to respond to a
`highly diverse workload, including unanticipated public health needs. FDA is committed to
`meeting the performance goals specified in this letter and to continuous improvement of its
`performance regarding other important areas specified in relevant published documents1 that
`relate to preapproval drug development and post-approval activities for marketed products. FDA
`and the regulated industry will periodically and regularly assess the progress of the human drug
`review program throughout PDUFA VI. This will allow FDA and the regulated industry to
`identify emerging challenges and develop strategies to address these challenges to ensure the
`efficiency and effectiveness of the human drug review program.
`
`Unless otherwise stated, goals apply to cohorts of each fiscal year (FY).
`
`
`
`
`1 Refer to the Good Review Management Principles and Practices for PDUFA Products guidance (hereinafter
`referred to as “GRMP guidance”) available at http://www fda.gov/downloads/Drugs/.../Guidances/ucm079748.pdf
`and the Good Review Management Principles and Practices for Effective IND Development and Review MAPP
`(hereinafter referred to as “GRMP MAPP”) available at
`http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofP
`oliciesProcedures/UCM349907.pdf
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`I. ENSURING THE EFFECTIVENESS OF THE HUMAN DRUG REVIEW
`PROGRAM
`
`A. REVIEW PERFORMANCE GOALS
`
`1. NDA/BLA Submissions and Resubmissions2
`
`
`
`a. Review and act on 90 percent of standard NME NDA and original BLA
`submissions within 10 months of the 60 day filing date.
`b. Review and act on 90 percent of priority NME NDA and original BLA
`submissions within 6 months of the 60 day filing date.
`c. Review and act on 90 percent of standard non-NME original NDA
`submissions within 10 months of receipt.
`d. Review and act on 90 percent of priority non-NME original NDA
`submissions within 6 months of receipt.
`e. Review and act on 90 percent of Class 1 resubmitted original
`applications within 2 months of receipt.
`f. Review and act on 90 percent of Class 2 resubmitted original
`applications within 6 months of receipt.
`
`2. Original Efficacy Supplements
`
`a. Review and act on 90 percent of standard efficacy supplements within
`10 months of receipt.
`b. Review and act on 90 percent of priority efficacy supplement within 6
`months of receipt.
`
`3. Resubmitted Efficacy Supplements
`
`a. Review and act on 90 percent of Class 1 resubmitted efficacy
`supplements within 2 months of receipt.
`b. Review and act on 90 percent of Class 2 resubmitted efficacy
`supplements within 6 months of receipt.
`
`
`
`2 Refer to Section I.B for a description of the review program for NME NDAs and original BLAs.
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`4. Original Manufacturing Supplements
`
`
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`a. Review and act on 90 percent of manufacturing supplements requiring
`prior approval within 4 months of receipt
`b. Review and act on 90 percent of all other manufacturing supplements
`within 6 months of receipt.
`
`5. Review Performance Goal Extensions
`
`a. Major Amendments
`
`i. A major amendment to an original application, efficacy supplement,
`or resubmission of any of these applications, submitted at any time
`during the review cycle, may extend the goal date by three months.
`ii. A major amendment may include, for example, a major new clinical
`safety/efficacy study report; major re-analysis of previously
`submitted study(ies); submission of a Risk Evaluation and
`Mitigation Strategy (REMS) with Element to Assure Safe Use
`(ETASU) not included in the original application; or significant
`amendment to a previously submitted REMS with ETASU.
`Generally, changes to REMS that do not include ETASU and minor
`changes to REMS with ETASU will not be considered major
`amendments.
`iii. A major amendment to a manufacturing supplement submitted at any
`time during the review cycle may extend the goal date by two
`months.
`iv. Only one extension can be given per review cycle.
`v. Consistent with the underlying principles articulated in the GRMP
`guidance, FDA’s decision to extend the review clock should, except
`in rare circumstances, be limited to occasions where review of the
`new information could address outstanding deficiencies in the
`application and lead to approval in the current review cycle.
`
`b. Inspection of Facilities Not Adequately Identified in an Original
`Application or Supplement
`
`i. All original applications, including those in the “Program,” (see
`Section I.B.2) and supplements are expected to include a
`comprehensive and readily located list of all manufacturing facilities
`included or referenced in the application or supplement. This list
`provides FDA with information needed to schedule inspections of
`manufacturing facilities that may be necessary before approval of the
`original application or supplement.
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`ii.
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`If, during FDA’s review of an original application or supplement, the
`Agency identifies a manufacturing facility that was not included in the
`comprehensive and readily located list, the goal date may be extended.
`
`1) If FDA identifies the need to inspect a manufacturing
`facility that is not included as part of the comprehensive
`and readily located list in an original application or efficacy
`supplement, the goal date may be extended by three
`months.
`2) If FDA identifies the need to inspect a manufacturing
`facility that is not included as part of the comprehensive
`and readily located list in a manufacturing supplement, the
`goal date may be extended by two months.
`
`6. These review goals are summarized in the following tables:
`
`NME NDAs and original BLAs
`
`Table 1: Original and Resubmitted Applications and Supplements:
`SUBMISSION COHORT
`STANDARD
`90% in 10 months of the
`60 day filing date
`90% in 10 months of the
`receipt date
`90% in 2 months of the
`receipt date
`90% in 6 months of the
`receipt date
`90% in 10 months of the
`receipt date
`90% in 2 months of the
`receipt date
`90% in 6 months of the
`receipt date
`
`Non NME NDAs
`
`Class 1 Resubmissions
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`Class 2 Resubmissions
`
`Original Efficacy Supplements
`
`Class 1 Resubmitted Efficacy
`Supplements
`Class 2 Resubmitted Efficacy
`Supplements
`
`PRIORITY
`90% in 6 months of the
`60 day filing date
`90% in 6 months of the
`receipt date
`90% in 2 months of the
`receipt date
`90% in 6 months of the
`receipt date
`90% in 6 months of the
`receipt date
`90% in 2 months of the
`receipt date
`90% in 6 months of the
`receipt date
`
`Table 2:
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`Manufacturing Supplements
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`
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`PRIOR APPROVAL
`90% in 4 months of the
`receipt date
`
`ALL OTHER
`90% in 6 months of the
`receipt date
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`B. PROGRAM FOR ENHANCED REVIEW TRANSPARENCY AND
`COMMUNICATION FOR NME NDAs AND ORIGINAL BLAs
`
`
`
`To promote transparency and communication between the FDA review team and the
`applicant, FDA will apply the following model (“the Program”) to the review of all New
`Molecular Entity New Drug Applications (NME NDAs) and original Biologics License
`Applications (BLAs), including applications that are resubmitted following a Refuse-to-
`File decision, received from October 1, 2017, through September 30, 2022.3 The goal of
`the Program is to promote the efficiency and effectiveness of the first cycle review
`process and minimize the number of review cycles necessary for approval, ensuring that
`patients have timely access to safe, effective, and high quality new drugs and biologics.
`
`Approach to Application Review. The standard approach for the review of NME
`NDAs and original BLAs is described in this section. However, the FDA review team
`and the applicant may discuss and reach mutual agreement on an alternative approach to
`the timing and nature of interactions and information exchange between the applicant and
`FDA, i.e., a Formal Communication Plan for the review of the NME NDA or original
`BLA. The Formal Communication Plan may include elements of the standard approach
`(e.g., a mid-cycle communication or a late-cycle meeting) as well as other interactions
`that sometimes occur during the review process (e.g., a meeting during the filing period
`to discuss the application, i.e., an “application orientation meeting”). If appropriate, the
`Formal Communication Plan should specify those elements of the Program that FDA and
`the sponsor agree are unnecessary for the application under review. If the review team
`and the applicant anticipate developing a Formal Communication Plan, the elements of
`the plan should be discussed and agreed to at the pre-submission meeting (see Section
`I.B.1) and reflected in the meeting minutes. The Formal Communication Plan may be
`reviewed and amended at any time based on the progress of the review and the mutual
`agreement of the review team and the applicant. For example, the review team and the
`applicant may mutually agree at any time to cancel future specified interactions in the
`Program (e.g., the late-cycle meeting) that become unnecessary (e.g. because previous
`communications between the review team and the applicant are sufficient). Any
`amendments made to the Formal Communication Plan should be consistent with the goal
`of an efficient and timely first cycle review process and not impede the review team’s
`ability to conduct its review.
`
`Expedited Reviews. In certain cases, an application reviewed in the Program will be for
`a product that the FDA review team identifies as meeting an important public health
`need. If the FDA review team determines that a first-cycle approval is likely for such an
`
`
`3 The decision as to whether the application is included or excluded from the Program is distinct
`from FDA's determination as to whether the drug product contains a "new chemical entity," as defined under 21
`CFR 314.108(a). Determinations regarding new chemical entity exclusivity are made at the time of approval of an
`application.
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`application, the team intends to make every effort to conduct an expedited review4 and
`act early on the application. FDA conducts expedited reviews to promote timely access to
`critically needed therapies for patients without compromising FDA’s high standards for
`demonstrating the safety, efficacy, and quality of new medicines. Expedited reviews are
`typically characterized by frequent contact between the applicant and the FDA review
`team throughout the review process. Any parameters of the Program that are intended to
`facilitate expedited reviews are noted throughout Section I.B.
`
`If significant application deficiencies are identified by the review team at any time during
`an expedited review, FDA intends to revert, for the remainder of the review, to the
`standard approach to the review of priority NME NDAs and original BLAs (as described
`in this section), and will inform the applicant accordingly.
`
`The remainder of Section I.B describes the parameters that will apply to FDA’s review of
`applications in the Program.
`
`1. Pre-submission meeting: The applicant is strongly encouraged to discuss the
`planned content of the application with the appropriate FDA review division at a pre-
`NDA/BLA meeting. This meeting will be attended by the FDA review team, including
`appropriate senior FDA staff.
`
`a. The pre-NDA/BLA meeting should be held sufficiently in advance of the
`planned submission of the application to allow for meaningful response to
`FDA feedback and should generally occur not less than 2 months prior to the
`planned submission of the application.
`
`b. In addition to FDA’s preliminary responses to the applicant’s questions, other
`potential discussion topics include preliminary discussions on the need for
`REMS or other risk management actions, and, where applicable, the
`development of a Formal Communication Plan and a timeline for review
`activities associated with a scheduling recommendation under the Controlled
`Substances Act for drugs with abuse potential. These discussions will be
`summarized at the conclusion of the meeting and reflected in the FDA
`meeting minutes.
`
`c. The FDA and the applicant will agree on the content of a complete application
`for the proposed indication(s) at the pre-submission meeting. The FDA and
`the applicant may also reach agreement on submission of a limited number of
`application components not later than 30 calendar days after the submission of
`
`4 The term “expedited review” in this letter refers to FDA’s review of a human drug application that has received
`priority review designation where the review team plans to act at least 1 month before the PDUFA goal date
`provided that no significant application deficiencies prevent an early action. Expedited review is distinguished from
`FDA’s expedited programs: fast track designation, breakthrough therapy designation, accelerated approval, and
`priority review. The decision to perform an expedited review of an application is independent of decisions regarding
`these expedited programs. Applications that are identified as candidates for expedited review may be reviewed
`under any one or more of FDA’s expedited programs.
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`the original application. These submissions must be of a type that would not
`be expected to materially impact the ability of the review team to begin its
`review. These agreements will be summarized at the conclusion of the
`meeting and reflected in the FDA meeting minutes.
`
`i. Examples of application components that may be appropriate for delayed
`submission include updated stability data (e.g., 15-month data to update
`12-month data submitted with the original submission) or the final audited
`report of a preclinical study (e.g., carcinogenicity) where the final draft
`report is submitted with the original application.
`
`ii. Major components of the application (e.g., the complete study report of a
`Phase 3 clinical trial or the full study report of required long-term safety
`data) are expected to be submitted with the original application and are not
`subject to agreement for late submission.
`
`2. Original application submission: Applications are expected to be complete, as
`agreed between the FDA review team and the applicant at the pre-NDA/BLA meeting, at
`the time of original submission of the application. If the applicant does not have a pre-
`NDA/BLA meeting with FDA, and no agreement exists between FDA and the applicant
`on the contents of a complete application or delayed submission of certain components of
`the application, the applicant’s submission is expected to be complete at the time of
`original submission.
`
`a. All applications are expected to include a comprehensive and readily located
`list of all clinical sites and manufacturing facilities included or referenced in
`the application.
`
`b. Any components of the application that FDA agreed at the pre-submission
`meeting could be submitted after the original application are expected to be
`received not later than 30 calendar days after receipt of the original
`application.
`
`c. Incomplete applications, including applications with components that are not
`received within 30 calendar days after receipt of the original submission, will
`be subject to a Refuse-to-File decision.
`
`d. The following parameters will apply to applications that are subject to a
`Refuse-to-File decision and are subsequently filed over protest:
`
`i. The original submission of the application will be subject to the review
`performance goal as described in Section I.B.4.
`
`ii. The application will not be eligible for the other parameters of the
`Program (e.g., mid-cycle communication, late-cycle meeting)
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`iii.
`
`FDA generally will not review amendments to the application during any
`review cycle. FDA also generally will not issue information requests to
`the applicant during the agency’s review.
`
`iv. The resubmission goals described in Section I.A.1.e and I.A.1.f will not
`apply to any resubmission of the application following an FDA complete
`response action. Any such resubmission will be reviewed as available
`resources permit.
`
`e. Since applications are expected to be complete at the time of submission,
`unsolicited amendments are expected to be rare and not to contain major new
`information or analyses. Review of unsolicited amendments, including those
`submitted in response to an FDA communication of deficiencies, will be
`handled in accordance with the GRMP guidance. This guidance includes the
`underlying principle that FDA will consider the most efficient path toward
`completion of a comprehensive review that addresses application deficiencies
`and leads toward a first cycle approval when possible.
`
`3. Day 74 Letter: FDA will follow existing procedures regarding identification and
`communication of filing review issues in the “Day 74 letter.” For applications subject to
`the Program, the timeline for this communication will be within 74 calendar days from
`the date of FDA receipt of the original submission. The planned review timeline
`included in the Day 74 letter for applications in the Program will include the planned date
`for the internal mid-cycle review meeting. The letter will also include preliminary plans
`on whether to hold an Advisory Committee (AC) meeting to discuss the application. If
`applicable, the Day 74 letter will serve as notification to the applicant that the review
`division intends to conduct an expedited review.
`
`4. Review performance goals: For NME NDA and original BLA submissions that are
`filed by FDA under the Program, the PDUFA review clock will begin at the conclusion
`of the 60 calendar day filing review period that begins on the date of FDA receipt of the
`original submission. The review performance goals for these applications are as follows:
`
`a. Review and act on 90 percent of standard NME NDA and original BLA
`submissions within 10 months of the 60 day filing date.
`
`b. Review and act on 90 percent of priority NME NDA and original BLA
`submissions within 6 months of the 60 day filing date.
`
`5. Mid-Cycle Communication: The FDA Regulatory Project Manager (RPM), and
`other appropriate members of the FDA review team (e.g., Cross Discipline Team Leader
`(CDTL)), will call the applicant, generally within 2 weeks following the Agency’s
`internal mid-cycle review meeting, to provide the applicant with an update on the status
`of the review of their application. An agenda will be sent to the applicant prior to the
`mid-cycle communication. Scheduling of the internal mid-cycle review meeting will be
`handled in accordance with the GRMP guidance. The RPM will coordinate the specific
`date and time of the telephone call with the applicant.
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`a. The update should include any significant issues identified by the review team
`to date, any information requests, information regarding major safety concerns
`and preliminary review team thinking regarding risk management, proposed
`date(s) for the late-cycle meeting, updates regarding plans for the AC meeting
`(if an AC meeting is anticipated), an update regarding FDA’s review activities
`associated with a scheduling recommendation under the Controlled
`Substances Act (if applicable), and other projected milestone dates for the
`remainder of the review cycle.
`
`b. In the case of an expedited review, FDA will communicate the timelines for
`the Late-Cycle Meeting and the Late-Cycle Meeting background package (see
`Section I.B.6) which may occur earlier with more condensed timeframes
`compared to a review that is not expedited.
`
`6. Late-Cycle and Advisory Committee Meetings: A meeting will be held between
`the FDA review team and the applicant to discuss the status of the review of the
`application late in the review cycle. Late-cycle meetings will generally be face-to-face
`meetings; however, the meeting may be held by teleconference if FDA and the applicant
`agree. Since the application is expected to be complete at the time of submission, FDA
`intends to complete primary and secondary reviews of the application in advance of the
`planned late-cycle meeting.
`
`a. FDA representatives at the late-cycle meeting are expected to include the
`signatory authority for the application, review team members from appropriate
`disciplines, and appropriate team leaders and/or supervisors from disciplines
`for which substantive issues have been identified in the review to date.
`
`b. For applications that will be discussed at an AC meeting, the following
`parameters apply:
`
`i.
`
`ii.
`
`iii.
`
`FDA intends to convene AC meetings no later than 2 months (standard
`review) or no later than 6 weeks (priority review) prior to the PDUFA goal
`date. The late-cycle meeting will occur not less than 12 calendar days
`before the date of the AC meeting.
`
`FDA intends to provide final questions for the AC to the sponsor and the
`AC not less than 2 calendar days before the AC meeting.
`
`Following an AC Meeting, FDA and the applicant may agree on the need
`to discuss feedback from the AC for the purpose of facilitating the
`remainder of the review. Such a meeting will generally be held by
`teleconference without a commitment for formal meeting minutes issued
`by the agency.
`
`c. For applications that will not be discussed at an AC meeting, the late-cycle
`meeting will generally occur not later than 3 months (standard review) or two
`months (priority review) prior to the PDUFA goal date.
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`d. Late-Cycle Meeting Background Packages: The Agency background package
`for the late-cycle meeting will be sent to the applicant not less than 10
`calendar days (or 2 calendar days for an expedited review) before the late-
`cycle meeting. The package will consist of a brief memorandum from the
`review team outlining substantive application issues (e.g., deficiencies
`identified by primary and secondary reviews), the Agency’s background
`package for the AC meeting (incorporated by reference if previously sent to
`the applicant), potential questions and/or points for discussion for the AC
`meeting (if planned) and the current assessment of the need for REMS or
`other risk management actions. If the application is subject to an expedited
`review, the background package may be streamlined and brief using a bulleted
`list to identify issues to be discussed.
`
`e. Late-Cycle Meeting Discussion Topics: Potential topics for discussion at the
`late-cycle meeting include major deficiencies identified to date; issues to be
`discussed at the AC meeting (if planned); current assessment of the need for
`REMS or other risk management actions; status update of FDA’s review
`activities associated with a scheduling recommendation under the Controlled
`Substances Act, if applicable; information requests from the review team to
`the applicant; and additional data or analyses the applicant may wish to
`submit.
`
`i. With regard to submission of additional data or analyses, the FDA review
`team and the applicant will discuss whether such data will be reviewed by
`the Agency in the current review cycle and, if so, whether the submission
`will be considered a major amendment and trigger an extension of the
`PDUFA goal date.
`
`7. Inspections: FDA’s goal is to complete all GCP, GLP, and GMP inspections for
`applications in the Program within 6 months of the date of original receipt for priority
`applications and within 10 months of the date of original receipt for standard
`applications. This will allow 2 months at the end of the review cycle to attempt to
`address any deficiencies identified by the inspections.
`
`C. FIRST CYCLE REVIEW MANAGEMENT
`
`FDA and industry share a commitment to ensuring an efficient and effective first cycle review
`process for all applications subject to the PDUFA program. This commitment was first
`articulated in the GRMP guidance finalized in 2005. FDA will update this guidance in PDUFA
`VI to include review activities (e.g., the NME Program, REMS) that have been added to the
`human drug review program since the guidance was finalized, principles regarding notification
`to applicants regarding issues identified during FDA’s initial review of the application, principles
`regarding FDA’s notification to applicants regarding planned review timelines, and the
`importance of internal review timelines that govern aspects of the human drug review program
`that are not part of PDUFA performance goals. FDA will publish a revised draft guidance for
`public comment no later than the end of FY 2018.
`
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`D. REVIEW OF PROPRIETARY NAMES TO REDUCE MEDICATION ERRORS
`
`To enhance patient safety, FDA is committed to various measures to reduce medication errors
`related to look-alike and sound-alike proprietary names and such factors as unclear label
`abbreviations, acronyms, dose designations, and error prone label and packaging design. The
`following performance goals apply to FDA’s review of drug and biological product proprietary
`names during development (as early as end-of-phase 2) and during FDA’s review of a marketing
`application:
`
`1. Proprietary Name Review Performance Goals During Drug Development
`
`a. Review 90% of proprietary name submissions filed within 180 days of receipt.
`Notify sponsor of tentative acceptance or non-acceptance.
`b. If the proprietary name is found to be unacceptable, the sponsor can request
`reconsideration by submitting a written rebuttal with supporting data or
`request a meeting within 60 days to discuss the initial decision (meeting
`package required).
`c. If the proprietary name is found to be unacceptable, the above review
`performance goals also would apply to the written request for reconsideration
`with supporting data or the submission of a new proprietary name.
`d. A complete submission is required to begin the review clock.
`
`2. Proprietary Name Review Performance Goals During Application Review
`
`a. Review 90% of NDA/BLA proprietary name submissions filed within 90 days
`of receipt. Notify sponsor of tentative acceptance/non-acceptance.
`b. A supplemental review will be done meeting the above review performance
`goals if the proprietary name has been submitted previously (IND phase after
`end-of-phase 2) and has received tentative acceptance.
`c. If the proprietary name is found to be unacceptable, the sponsor can request
`reconsideration by submitting a written rebuttal with supporting data or
`request a meeting within 60 days to discuss the initial decision (meeting
`package required).
`d. If the proprietary name is found to be unacceptable, the above review
`performance goals apply to the written request for reconsideration with
`supporting data or the submission of a new proprietary name.
`e. A complete submission is required to begin the review clock.
`
`E. MAJOR DISPUTE RESOLUTION
`
`1. Procedure:
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`For procedural or scientific matters involving the review of human drug applications and
`supplements (as defined in PDUFA) that cannot be resolved at the signatory authority
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`level (including a request for reconsideration by the signatory authority after reviewing
`any materials that are planned to be forwarded with an appeal to the next level), the
`response to appeals of decisions will occur within 30 calendar days of the Center’s
`receipt of the written appeal.
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`2. Performance goal:
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`90% of such answers are provided within 30 calendar days of the Center’s receipt of the
`written appeal.
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`3. Conditions:
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`a. Sponsors should first try to resolve the procedural or scientific issue at the
`signatory authority level. If it cannot be resolved at that level, it should be
`appealed to the next higher organizational level (with a copy to the signatory
`authority) and then, if necessary, to the next higher organizational level.
`b. Responses should be either verbal (followed by a written confirmation within
`14 calendar days of the verbal notification) or written and should ordinarily be
`to either grant or deny the appeal.
`c. If the decision is to deny the appeal, the response should include reasons for
`the denial and any actions the sponsor might take to persuade the Agency to
`reverse its decision.
`d. In some cases, further data or further input from others might be needed to
`reach a decision on the appeal. In these cases, the “response” should be the
`plan for obtaining that information (e.g., requesting further information from
`the sponsor, scheduling a meeting with the sponsor, scheduling the issue for
`discussion at the next scheduled available advisory committee (AC).
`e. In these cases, once the required information is received by the Agency
`(including any advice from an AC), the person to whom the appeal was made,
`again has 30 calendar days from the receipt of the required information in
`which to either grant or deny the appeal.
`f. Again, if the decision is to deny the appeal, the response should include the
`reasons for the denial and any actions the sponsor might take to persuade the
`Agency to reverse its decision.
`g. N.B. If the Agency decides to present the issue to an AC and there are not 30
`days before the next scheduled AC, the issue will be presented at the
`following scheduled committee meeting to allow conformance with AC
`administrative procedures.
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`F. CLINICAL HOLDS
`1. Procedure:
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`The Center should respond to a sponsor’s complete response to a clinical hold within 30
`days of the Agency’s receipt of the submission of such sponsor response.
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`2. Performance goal:
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`90% of such responses are provided within 30 calendar days of the Agency’s rec