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How to Work with FDA: Industry Perspective IVD Roundtable/OIVD Workshop. Mark A. Del Vecchio Director, Regulatory and Clinical Affairs Digene Corporation. April 22, 2003. Discussion Topics. Interaction with FDA General Considerations Before you Submit During the Review

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Mark A. Del Vecchio Director, Regulatory and Clinical Affairs Digene Corporation

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Mark a del vecchio director regulatory and clinical affairs digene corporation

How to Work with FDA:Industry PerspectiveIVD Roundtable/OIVD Workshop

Mark A. Del Vecchio

Director, Regulatory and Clinical Affairs

Digene Corporation

April 22, 2003


Discussion topics

Discussion Topics

  • Interaction with FDA

    • General Considerations

    • Before you Submit

    • During the Review

    • In the Home Stretch

  • Meetings with FDA

  • Use of Consultants

    • Regulatory

    • Statistical

  • Quality of Submitted Documents


Interaction with fda general considerations

Interaction with FDAGeneral Considerations

  • In the regulatory arena, your Company’s success is highly dependent on your working relationship and reputation with FDA

  • You have the right and the obligation to work with the Agency on your submission strategies

  • Be as up front as possible regarding your proposed submission strategy…it is important not to surprise the Agency

  • Honor the resulting commitments


Interaction with fda general considerations1

Interaction with FDAGeneral Considerations

  • Document all of your communications with FDA

    • This will help both you and FDA to easily refer to specifics of items discussed/agreed upon

    • Expands internal Company communication, clarifying corporate objectives when addressing issues with FDA

  • It is imperative that you discuss submission options with the appropriate review branch, particularly when proposing an “express” or novel route


Interaction with fda before you submit

Interaction with FDABefore you Submit

  • Establish which Center/ OIVD Division will review your submission

  • Determine the appropriate submission type

  • Discuss your proposed clinical study and submission with FDA review team

  • Draft Clinical Protocol should be available

    • Including the statistical analysis plan for the study data


Interaction with fda before you submit1

Interaction with FDABefore you Submit

  • It is critical that you have the Intended Use for the test clearly defined

  • This is the mechanism whereby FDA can determine the appropriateness of your clinical study to support the intended claim(s)

  • Significant time should be dedicated to ensuring FDA understands your claims and the type of data:

    • FDA expects to support these claims

    • You propose will adequately support these claims

  • Be prepared to provide rationale for the statistical approach to support your claims


Interaction with fda before you submit2

Interaction with FDABefore you Submit

  • Agreement on clinical trial design and submission strategy is very important

  • Amount of upfront discussion dependent on complexity and “unique” nature of the approach

  • Traditional approach – fewer unknowns

  • It is appropriate to discuss statistical issues directly with FDA statistician when necessary to minimize confusion or to clarify FDA’s position


Interaction with fda before you submit3

Interaction with FDABefore you Submit

  • Be prepared

    • Use CDRH/CBER Guidance Documents

    • Review Other Clearance/Approval Information

      • CDRH/CBER Website

      • FOI

    • Talk with other Industry RA professionals:

      • ADVAMED

      • AMDM

      • RAPS

    • Utilize regulatory and statistical consultants where appropriate


Interaction with fda before you submit4

Interaction with FDABefore you Submit

  • Major objectives of earlier interactions - to reach a common understanding with FDA regarding your plan to support the intended use you are evaluating via pre-clinical and clinical studies

  • Meet with FDA as often as necessary before submission until both parties are comfortable with approach

  • Minimal goal is to reach philosophical agreement with FDA on the approach, however, things could change

    • Try to minimize areas that could change as you go along

    • Bring major changes back to FDA for discussion


Interaction with fda during the review

Interaction with FDADuring the Review

  • Often times, FDA will request additional information in a fairly informal manner, handled primarily via phone and/or email

  • Only when the request is substantive will FDA issue a formal deficiency letter or written request for additional information; typically near the end of the review cycle

  • Try to work with FDA to get more statistical review feedback DURING the review


Interaction with fda during the review1

Interaction with FDADuring the Review

  • Much statistical discussion should take place before submission; however,

    • sometimes specific details not available until after a decision is made

    • atypical, but has occurred on several occasions recently

  • Work with OIVD to ensure that you have the opportunity to address statistical concerns prior to a decision

  • One reason it is critical to reach some form of agreement on statistical plan before start of the study and prior to submission


Interaction with fda in the home stretch

Interaction with FDAIn the Home Stretch

  • Just prior to an FDA decision (2-3 weeks)

  • Most of the technical details worked out…FDA has a good understanding of the results of your clinical study and data available to support application

  • Much of this time spent on the specific details of the product labeling (PI)

  • May involve modifying your intended use statement to better reflect study data

  • The type/extent of data that can be included in the PI will be discussed

  • Last minute administrative details are addressed


Interaction with fda in the home stretch1

Interaction with FDAIn the Home Stretch

  • Very critical period, since time often running out to make a decision

  • Respond quickly to FDA requests

  • Utilize email as much as possible…good means to communicate

    • Accurate, written record

    • Very rapid

    • Can submit hard-copy email comms with final amendment if requested by Reviewer


Meeting with fda

Meeting with FDA

Recommended points in the process to meet with FDA (teleconference or face-to-face):

  • When first formulating your regulatory approach

    • Submission type

    • Correct review branch/division

  • Prior to initiation of clinical study

    • Draft clinical protocol should be available

    • Proposed Intended Use

    • Data analysis plan


Meeting with fda1

Meeting with FDA

Recommended points in the process to meet with FDA (teleconference or face-to-face):

  • Prior to Submission

    • following initial data analysis

    • particularly if statistical issues were raised during earlier meetings

  • During the review if necessary

    • to respond to questions/identified deficiencies with the application


Meeting with fda2

Meeting with FDA

Whenever you teleconference with FDA :

  • Provide talking points prior to the call, if time permits

  • Determine the participants required on the call, both for you and FDA

  • Sometimes a one-on-one with the Lead Reviewer is best

  • FDA is very responsive to setting up teleconferences in a timely manner

  • Gone are the days you could not contact your reviewer for several days


Meeting with fda3

Meeting with FDA

Whenever you meet face-to-face with FDA :

  • Provide agenda, talking points, data package prior to meeting at least 1 week in advance

  • Allow 3-4 weeks to schedule meeting with FDA; schedules are tight and you want all the essential people in the room when discussing your submission

  • Decide whether a formal presentation is appropriate…recommended approach

  • Conduct several “rehearsals” in-house prior to the meeting


Meeting with fda4

Meeting with FDA

Whenever you meet face-to-face with FDA :

  • Have your regulatory and/or statistical consultants with you for the meeting

  • FDA will always have a statistician participate in the meeting, particularly if clinical trial design or data analysis is being discussed

  • Before the meeting, prepare questions (with the responses) you anticipate FDA will ask

  • Have your technical staff with you as well, particularly to address unanticipated questions from the Review Team


Meeting with fda5

Meeting with FDA

Follow-up after the meeting with minutes to your Lead Reviewer or a “Memo of Understanding” so that key points and decisions made during the meeting are documented

  • Serves to resolve any miscommunication immediately

  • Helps facilitate clear understanding of action items and time commitments


Utilizing consultants

Utilizing Consultants

  • Highly recommended when interacting with FDA, particularly if you:

    • Are taking a novel approach

    • New to the industry

    • Bringing a product to a different review branch/division or Center

    • Do not have dedicated in-house statistical support

  • Typically have a greater range of contacts and experience with FDA

  • Can suggest approaches taken in other Centers or other Divisions within ODE/OIVD

  • Provide objective external review of submission


Quality of submitted documents

Quality of Submitted Documents

  • The success of your submission is greatly dependent on FDA’s ability to read and understand the document

  • Pre-submission interaction will greatly enhance the quality and clarity of the documents

  • Respect the fact that FDA reviewers handle several submissions simultaneously and therefore must make very efficient use of time spent on a single submission

  • Very important that the information in the submission build on an orderly presentation of history, facts, and data


Quality of submitted documents1

Quality of Submitted Documents

It is imperative that your documents are:

  • Well-organized

    • TOC

    • Clear, consistent pagination

    • Labeled section tabs

  • Thorough, clear, and concise in your descriptions

    • Use Summary Tables as much as possible

    • Do not assume FDA “remembers”:

      • Conversations

      • Prior submissions

      • Details of your product


Quality of submitted documents2

Quality of Submitted Documents

  • If it is critical that a particular point be communicated to FDA, repeat it several times in different sections of the application

  • Always reiterate important background information

  • If your submission is lengthy, use this tactic more often

  • When cross-referencing other submissions or even volumes of same submission, provide a summary of information to eliminate “flipping back and forth” between documents

  • When responding to specific FDA questions, always restate the question immediately prior to your written response


Quality of submitted documents3

Quality of Submitted Documents

  • When reviewing documents internally prior to submission, assume no prior knowledge

  • Have an outside party review documents

    • Regulatory consultant

    • Statistical consultant

    • Another department member within your organization, but not involved in the project


Quality of submitted documents4

Quality of Submitted Documents

  • Confusing, mis-numbered tables

  • Poor organization

  • Improper pagination

  • Wordy, unclear text

All of these lead to:

  • Frustration

  • Misunderstandings

  • Unnecessary, redundant communications

  • Multiple Review cycles

Increased review times


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