Feldman 13 Nov 2007 1 Meetings with FDA Martha A. Feldman, RAC Drug & Device Development Co., Inc....

Feldman 13 Nov 2007Feldman 13 Nov 2007 11

Meetings with FDAMeetings with FDAMartha A. Feldman, RACMartha A. Feldman, RAC

Drug & Device Development Co., Drug & Device Development Co., Inc.Inc.

UWE Biomedical Regulatory AffairsUWE Biomedical Regulatory Affairs


Topics for this SessionTopics for this Session

FDA’s views on meetingsFDA’s views on meetings Kinds of Meetings: drug/biotech and Kinds of Meetings: drug/biotech and

medical device productsmedical device products Types of Meetings for PDUFA ProductsTypes of Meetings for PDUFA Products Make request for a meetingMake request for a meeting Prepare for MeetingPrepare for Meeting Participate in MeetingParticipate in Meeting Follow-up to MeetingFollow-up to Meeting MiscellaneousMiscellaneous


FDA’s View of MeetingsFDA’s View of Meetings

FDA is committed to communicating and FDA is committed to communicating and interacting with sponsorsinteracting with sponsors

FDA believes face-to-face meetings benefit FDA believes face-to-face meetings benefit both sponsor and agency both sponsor and agency

FDA believes meetings are cost-effective in FDA believes meetings are cost-effective in the long run for both sponsor and agencythe long run for both sponsor and agency

This slide and several of the following slides are abstracted This slide and several of the following slides are abstracted from Elisa D. Harvey, “Understanding the Pre-IDE Program: from Elisa D. Harvey, “Understanding the Pre-IDE Program: FDA Perspective”, 25 May 2005 FDA Perspective”, 25 May 2005

http://www.fda.gov/cdrh/present/advamed-052505-harvey/index_files/index.hthttp://www.fda.gov/cdrh/present/advamed-052505-harvey/index_files/index.htmlml


Kinds of Meetings - 1Kinds of Meetings - 1

Drugs and Therapeutic BiologicsDrugs and Therapeutic Biologics– Pre-clinical Research MeetingPre-clinical Research Meeting– Pre-IND MeetingPre-IND Meeting– End of Phase 2/Pre-Phase 3 MeetingEnd of Phase 2/Pre-Phase 3 Meeting– Clinical Hold MeetingsClinical Hold Meetings– Pre-NDA MeetingPre-NDA Meeting– Advisory Committee MeetingAdvisory Committee Meeting– End of Review ConferenceEnd of Review Conference– Refusal to File ConferenceRefusal to File Conference– Pre-NDA Supplement MeetingPre-NDA Supplement Meeting


Kinds of Meetings - 2Kinds of Meetings - 2 Medical DevicesMedical Devices

– Scientific Meeting/Prior to proof of concept animal studiesScientific Meeting/Prior to proof of concept animal studies– Early Collaboration Meetings (Agreement and/or Early Collaboration Meetings (Agreement and/or

Determination)Determination)– Pre-IDE Meeting/Post-feasibility/Pre-Pivotal Study MeetingPre-IDE Meeting/Post-feasibility/Pre-Pivotal Study Meeting– Informal Pre-IDE MeetingsInformal Pre-IDE Meetings– Other Device MeetingsOther Device Meetings

Pre-PMA MeetingPre-PMA Meeting 100-Day PMA Meetings100-Day PMA Meetings Post-deficiency letter for 510(k) or PMAPost-deficiency letter for 510(k) or PMA Appeal of final decision on PMA, 510(k), IDE disapprovalAppeal of final decision on PMA, 510(k), IDE disapproval

– Advisory Committee MeetingAdvisory Committee Meeting


FDA-SPONSOR FDA-SPONSOR MEETINGS - DRUGSMEETINGS - DRUGS


Pre-clinical Research Pre-clinical Research MeetingsMeetings

Meetings are for the purpose of reaching Meetings are for the purpose of reaching agreements on the design and size of agreements on the design and size of clinical study for effectiveness claimclinical study for effectiveness claim

Special Protocol, Pharm/ToxSpecial Protocol, Pharm/Tox– Only on the pharm/tox portionOnly on the pharm/tox portion

Special protocol, ChemistrySpecial protocol, Chemistry– Only on the chemistry portionOnly on the chemistry portion

Special Protocol, MedicalSpecial Protocol, Medical– Only for the medical portionOnly for the medical portion


Pre-IND Meeting - 1Pre-IND Meeting - 1

CDER needs data that the drug is CDER needs data that the drug is reasonably safe for use in initial small-reasonably safe for use in initial small-scale clinical studiesscale clinical studies

The sponsor would request a meeting The sponsor would request a meeting with the appropriate review division.with the appropriate review division.

Discussions will include animal Discussions will include animal protocols, clinical testing phases, data protocols, clinical testing phases, data requirements, and scientific issues requirements, and scientific issues needing resolution prior to clinical needing resolution prior to clinical studiesstudies


Pre-IND Meeting - 2Pre-IND Meeting - 2

Chemistry, Manufacturing and Controls Chemistry, Manufacturing and Controls (CMC) Pre-IND meeting may be part of (CMC) Pre-IND meeting may be part of clinical meeting or separateclinical meeting or separate

Guidance document applies to both drugs Guidance document applies to both drugs and therapeutic biologics and therapeutic biologics http://www.fda.gov/cdr/guidance/3683fnl.htmhttp://www.fda.gov/cdr/guidance/3683fnl.htm

Topics covered in the meeting depend on Topics covered in the meeting depend on what Phase study is being conductedwhat Phase study is being conducted

Purpose: discuss CMC issues as they relate Purpose: discuss CMC issues as they relate to the safety of the new drug/biologic for to the safety of the new drug/biologic for the proposed indicationthe proposed indication


End of Phase 1 End of Phase 1

Sponsor may request a meeting after Sponsor may request a meeting after completion of Phase 1completion of Phase 1

Purpose is to review results and Purpose is to review results and reach agreement on plans for Phase reach agreement on plans for Phase 2 program2 program


End of Phase 2/Pre-Phase 3 End of Phase 2/Pre-Phase 3 MeetingMeeting

Primary purpose: to determine if it is Primary purpose: to determine if it is safe to proceed to Phase 3.safe to proceed to Phase 3.

Secondary purpose: to plan the Secondary purpose: to plan the protocol for the Phase 3 study, e.g., protocol for the Phase 3 study, e.g., the objectives, study designthe objectives, study design

Also, to discuss and identify any Also, to discuss and identify any additional information that may be additional information that may be required to support a NDA.required to support a NDA.


Critical Path MeetingCritical Path Meeting

Meeting which is held to help with a Meeting which is held to help with a stalled drug development program stalled drug development program

Purpose is to help program proceedPurpose is to help program proceed


Clinical Hold MeetingClinical Hold Meeting

At any point, the CDER can impose a At any point, the CDER can impose a clinical holdclinical hold, i.e., prohibit the study , i.e., prohibit the study from proceeding or to stop a study from proceeding or to stop a study that has started for reasons of that has started for reasons of safety, or because of a sponsor’s safety, or because of a sponsor’s failure to disclose the risk of the failure to disclose the risk of the study to the investigators.study to the investigators.


Pre-NDA/Pre-BLA meetingPre-NDA/Pre-BLA meeting

Primary purpose: to discuss the data in Primary purpose: to discuss the data in support of the application – filing and support of the application – filing and format issues format issues

Secondary purpose: to uncover any major Secondary purpose: to uncover any major unresolved problems or issues that might unresolved problems or issues that might lead to a “refuse to file” recommendationlead to a “refuse to file” recommendation

Also, to acquaint reviewers with the Also, to acquaint reviewers with the information submitted and to discuss how information submitted and to discuss how the data will be presented in the NDA.the data will be presented in the NDA.


90-Day Meeting90-Day Meeting

Occurs 90 days after the initial Occurs 90 days after the initial submissionsubmission

Purpose: to discuss any issues Purpose: to discuss any issues uncovered in the first stages of the uncovered in the first stages of the reviewreview


Advisory Committee Advisory Committee MeetingMeeting

Purposes:Purposes:– To solicit outside advice and opinions from expertsTo solicit outside advice and opinions from experts– Recommendations are nonbinding on CDERRecommendations are nonbinding on CDER

Issues that may be discussedIssues that may be discussed– Opinion about a new drugOpinion about a new drug– Opinion about new indication for an approved drugOpinion about new indication for an approved drug– Considerations about special regulatory Considerations about special regulatory

requirementsrequirements– Advice on necessary labelingAdvice on necessary labeling– Help with proposed studyHelp with proposed study– Assessing if safety and efficacy data are adequate Assessing if safety and efficacy data are adequate

support for the NDAsupport for the NDA


End of Review MeetingEnd of Review Meeting

Sponsor requests meeting to Sponsor requests meeting to determine what steps are needed to determine what steps are needed to be completed by the sponsor, what be completed by the sponsor, what additional information may be additional information may be required in order for the application required in order for the application to be approved.to be approved.


Refusal to File MeetingRefusal to File Meeting

The sponsor may request in writing a The sponsor may request in writing a meeting with CDER is it refuses to meeting with CDER is it refuses to file an applicationfile an application

If, after the meeting, the sponsor If, after the meeting, the sponsor wants the application, the FDA will do wants the application, the FDA will do so under protest.so under protest.


Pre-NDA(BLA)/Supplement Pre-NDA(BLA)/Supplement MeetingMeeting

The purpose of this meeting is to The purpose of this meeting is to acquaint the FDA reviewers with the acquaint the FDA reviewers with the general information to be submitted general information to be submitted – Discuss appropriate methods of Discuss appropriate methods of

statistical analysisstatistical analysis– Discuss proposed format for dataDiscuss proposed format for data– To identify the major supporting studiesTo identify the major supporting studies– Discuss any unresolved issuesDiscuss any unresolved issues


Other Possible MeetingsOther Possible Meetings

Advertising and promotion issuesAdvertising and promotion issues Biopharm and BioequivalenceBiopharm and Bioequivalence Compliance Compliance Electronic submissionsElectronic submissions LabelingLabeling Phase 4 Phase 4 Safety IssuesSafety Issues


KINDS OF MEETINGS KINDS OF MEETINGS – MEDICAL DEVICES– MEDICAL DEVICES


Scientific/Pre-proof of Concept Scientific/Pre-proof of Concept TestingTesting

Discuss concepts, broad outline of test Discuss concepts, broad outline of test plans, including need for certain bench plans, including need for certain bench studies, need for animal studies and studies, need for animal studies and need for clinical studies (no test results need for clinical studies (no test results needed, just plans, at this meeting)needed, just plans, at this meeting)

Discuss regulatory options, possible Discuss regulatory options, possible pathwayspathways

Discuss primary mode of action issues Discuss primary mode of action issues of a possible combination product; of a possible combination product; jurisdictional issuesjurisdictional issues


Early Collaboration Meetings Early Collaboration Meetings http://www.fda.gov/cdrh/ode/guidance/310.htmlhttp://www.fda.gov/cdrh/ode/guidance/310.html

Present early prototype evaluation in Present early prototype evaluation in preliminary animal modelspreliminary animal models

Discuss proposed clinical application, Discuss proposed clinical application, indication for useindication for use

Get FDA feedback on bench and animal Get FDA feedback on bench and animal study plans; feasibility study plans.study plans; feasibility study plans.

Start asking specific questions (e.g., Start asking specific questions (e.g., patient population; acceptable endpoints)patient population; acceptable endpoints)

Discuss probable regulatory pathway (non-Discuss probable regulatory pathway (non-binding discussion), including Risk binding discussion), including Risk Determination for device (SR/NSR) Determination for device (SR/NSR) http://www.fda.gov/cdrh/d861.htmlhttp://www.fda.gov/cdrh/d861.html


Pre-IDE Meeting/Post-Pre-IDE Meeting/Post-feasibility/Pre-Pivotal Study feasibility/Pre-Pivotal Study

MeetingMeeting Sponsor presents results of animal and Sponsor presents results of animal and

feasibility study; describe finalized device feasibility study; describe finalized device designdesign

Sponsor discusses pivotal trial protocol (1Sponsor discusses pivotal trial protocol (1° and ° and 2° endpoints, duration, statistical analysis and 2° endpoints, duration, statistical analysis and evaluation methods), including Indication for evaluation methods), including Indication for Use and patient populationUse and patient population

FDA gives feedback on above and on proposed FDA gives feedback on above and on proposed regulatory pathway, and nonbinding feedback regulatory pathway, and nonbinding feedback on expedited status, need for Advisory Panel on expedited status, need for Advisory Panel meetingmeeting

FDA gives feedback on focused questionsFDA gives feedback on focused questions


Pre-IDE MeetingsPre-IDE Meetings

AreAre– To provide feedback on To provide feedback on

preclinical test planpreclinical test plan– To provide feedback on To provide feedback on

clinical plansclinical plans– Determine what is Determine what is

Exempt/NSR Exempt/NSR investigationinvestigation

– To discuss international To discuss international (OUS) studies(OUS) studies

Are NotAre Not– A tool for negotiationA tool for negotiation– For modular reviewFor modular review– To preview dataTo preview data– For an in depth IDE For an in depth IDE

reviewreview– Legally bindingLegally binding– For dispute resolutionFor dispute resolution– To hold FDA to years-To hold FDA to years-

old informal feedbackold informal feedback– To be part of a series of To be part of a series of

such meetingssuch meetings


Informal Pre-IDE MeetingsInformal Pre-IDE Meetings

NotNot determination or agreement determination or agreement meetingsmeetings

Nothing bindingNothing binding May not have full review team presentMay not have full review team present Individual divisions may have their Individual divisions may have their

own checklists about what to submit own checklists about what to submit prior to the meeting – ascertain prior prior to the meeting – ascertain prior to sending packageto sending package


Other Device MeetingsOther Device Meetings

Pre-PMA MeetingPre-PMA Meeting 100-Day PMA Meeting100-Day PMA Meeting Post-deficiency letter for 510(k) or Post-deficiency letter for 510(k) or

PMAPMA Appeal of final decision on PMA, Appeal of final decision on PMA,

510(k), IDE disapproval510(k), IDE disapproval


Advisory Panel MeetingAdvisory Panel Meeting

Requirements (Section 513(b)(6)(B)Requirements (Section 513(b)(6)(B)– Must have adequate time for initial Must have adequate time for initial

presentationpresentation– Must have adequate time provided for Must have adequate time provided for

response to any differing views by response to any differing views by persons whose devices are the subject persons whose devices are the subject of a classification panelof a classification panel

– Must encourage free and open Must encourage free and open participation by all interested personsparticipation by all interested persons


Advisory PanelAdvisory Panel

Sponsor sends FDA material on Panel Sponsor sends FDA material on Panel presentationpresentation

FDA sends to the Sponsor the list of items it FDA sends to the Sponsor the list of items it will include in package to members of the will include in package to members of the PanelPanel

FDA sends package of materials to Panel FDA sends package of materials to Panel members; no new data provided within last 2 members; no new data provided within last 2 weeks prior to meetingweeks prior to meeting

Time lines for presentation to the Panel are Time lines for presentation to the Panel are provided in guidance document provided in guidance document http://www.fda.gov/cdrh/modact/amendpan.htmlhttp://www.fda.gov/cdrh/modact/amendpan.html


FDA Does Not Have FDA Does Not Have to Accept to Accept

Recommendations Recommendations from the Panelfrom the Panel


TYPES OF MEETINGS TYPES OF MEETINGS

Applies to both CDER and Applies to both CDER and CBERCBER


Type AType A

Is immediately necessary for a stalled Is immediately necessary for a stalled drug development program to proceeddrug development program to proceed

Occur within 30 days of sponsor’s Occur within 30 days of sponsor’s requestrequest

Examples:Examples:– Dispute resolution meetingsDispute resolution meetings– Clinical holdsClinical holds– Special protocol assessment after FDA Special protocol assessment after FDA

evaluationevaluation


Type BType B

Scheduled 60 days after receipt of Scheduled 60 days after receipt of sponsor requestsponsor request

Pre-IND meeting (21 CFR 312.82)Pre-IND meeting (21 CFR 312.82) Certain end of Phase 1 meetings Certain end of Phase 1 meetings

(21CFR 312.82)(21CFR 312.82) End of Phase 2/Pre-Phase 3 meetings End of Phase 2/Pre-Phase 3 meetings

(21 CFR 312.47)(21 CFR 312.47) Pre-NDA/BLA meetings (21 CFR 312.47)Pre-NDA/BLA meetings (21 CFR 312.47)


Type CType C

Any meeting other than a Type A or a Any meeting other than a Type A or a Type B meetingType B meeting

Examples of such meetingsExamples of such meetings– About advertisingAbout advertising– About promotional labelingAbout promotional labeling

Not Type C meetings – examplesNot Type C meetings – examples– about launch activities and materialsabout launch activities and materials– Postmarketing safety evaluation Postmarketing safety evaluation

meetingsmeetings


Requesting a Meeting Requesting a Meeting with FDAwith FDA


Whom to Meet WithWhom to Meet With Check Center’s organizational chart to Check Center’s organizational chart to

determine to which group to send meeting determine to which group to send meeting requestrequest

Call the division and give a brief overview of Call the division and give a brief overview of why a meeting is being requested, i.e., the why a meeting is being requested, i.e., the purpose and scope of the meeting; give purpose and scope of the meeting; give regulatory status of the product (e.g., new, re-regulatory status of the product (e.g., new, re-vamped in some way, new indication for vamped in some way, new indication for previously approved product)previously approved product)

Get a name of the person to whom the package Get a name of the person to whom the package should be addressed, usually the Branch Chiefshould be addressed, usually the Branch Chief

The package must be received before a The package must be received before a meeting is scheduled, usually about 2-3 weeks meeting is scheduled, usually about 2-3 weeks in advance.in advance.


Setting a dateSetting a date

Be flexible as to dates – give several Be flexible as to dates – give several possible dates and times.possible dates and times.

NOTE: If significant additional information NOTE: If significant additional information is submitted after the package has been is submitted after the package has been sent and after the meeting has been sent and after the meeting has been scheduled, the meeting might be scheduled, the meeting might be cancelled or postponed.cancelled or postponed.

If you have to cancel, do it at least 48 If you have to cancel, do it at least 48 hours ahead.hours ahead.


The CDER/CBER “Package” The CDER/CBER “Package” Includes:Includes:

Proposed agenda; list of attendees and Proposed agenda; list of attendees and affiliationsaffiliations

Product name, chemical name and structureProduct name, chemical name and structure Proposed indication(s)Proposed indication(s) Dosage form, route of administration, dosingDosage form, route of administration, dosing Study plans: bench, animal, clinicalStudy plans: bench, animal, clinical Summaries of prior animal or clinical data (as Summaries of prior animal or clinical data (as

appropriate for phase of study)appropriate for phase of study) Chemistry, Manufacturing and Controls (as Chemistry, Manufacturing and Controls (as

appropriate for Phase of study)appropriate for Phase of study) List of objectives/outcomes expected from List of objectives/outcomes expected from

meetingmeeting


The Device “Package” The Device “Package” Includes:Includes:

Proposed agenda (and time allotment) and Proposed agenda (and time allotment) and list of attendees and each person’s list of attendees and each person’s affiliationaffiliation

Background of clinical condition or diseaseBackground of clinical condition or disease Currently available products, balanced view Currently available products, balanced view

of pros and cons of eachof pros and cons of each Product description and rationale for use in Product description and rationale for use in

this condition or diseasethis condition or disease– intended use and indication for usintended use and indication for us

Test plans: bench, animal, clinicalTest plans: bench, animal, clinical List of questions to be addressed at meetingList of questions to be addressed at meeting


What FDA does when it Receives What FDA does when it Receives the Packagethe Package

Branch chief receives packageBranch chief receives package BC determines who will be on Review TeamBC determines who will be on Review Team BC assigns project to a lead reviewerBC assigns project to a lead reviewer Copies prepared (or requested of Sponsor) and Copies prepared (or requested of Sponsor) and

distributeddistributed Internal pre-meeting and sponsor meetings are Internal pre-meeting and sponsor meetings are

scheduledscheduled Team members review package and prepare Team members review package and prepare

memos prior to pre-meetingmemos prior to pre-meeting Internal pre-meeting held to discuss issues, reach Internal pre-meeting held to discuss issues, reach

consensus, get further information from consensus, get further information from Team/management Team/management


Preparing for a Preparing for a Meeting with FDAMeeting with FDA


Planning the Presentation-1Planning the Presentation-1

Use the time optimally. Use the time optimally. – Presentation of the agenda and list of Presentation of the agenda and list of

attendees should take no more than 2 minutesattendees should take no more than 2 minutes– Assume the FDA has read all of the material; Assume the FDA has read all of the material;

do not waste time in your presentation do not waste time in your presentation reviewing material sent in the package.reviewing material sent in the package.

Call a week ahead of meeting to see Call a week ahead of meeting to see if the Lead Reviewer can send you a if the Lead Reviewer can send you a list of the questions generated at list of the questions generated at their internal meeting.their internal meeting.


Planning the Presentation - Planning the Presentation - 22

The preliminary questions from the reviewing team The preliminary questions from the reviewing team may cover deficiencies and/or other issuesmay cover deficiencies and/or other issues

Compare your list of questions with the preliminary Compare your list of questions with the preliminary questions from the review team. Ensure your questions from the review team. Ensure your presentation will cover them and, if possible, presentation will cover them and, if possible, without presenting significant new information.without presenting significant new information.

Focus your presentation to elicit as much Focus your presentation to elicit as much information, comments, suggestions from the information, comments, suggestions from the agency.agency.

Manage the time by rehearsing presenters so that Manage the time by rehearsing presenters so that they keep to their time allotment. they keep to their time allotment.

Limit the number of presenters – too much time can Limit the number of presenters – too much time can be lost during change of speakers.be lost during change of speakers.


Preparing for the MeetingPreparing for the Meeting

Do a mock rehearsal with two groups Do a mock rehearsal with two groups of people:of people:– Those that know a lot about the product Those that know a lot about the product

and research - to ensure you have not and research - to ensure you have not omitted critical information and have omitted critical information and have included all possible issuesincluded all possible issues

– Those that do not know anything abut the Those that do not know anything abut the product and have read only the product and have read only the “package” - to ensure your presentation “package” - to ensure your presentation is comprehendible and flows smoothlyis comprehendible and flows smoothly


Participating in a Participating in a Meeting with FDAMeeting with FDA


The Meeting - 1The Meeting - 1

Get to the building early as there is a Get to the building early as there is a lengthy sign-in and inspection lengthy sign-in and inspection procedure.procedure.

Meetings are usually one hour long. Meetings are usually one hour long. They will start and end on time.They will start and end on time.

TURN OFF CELL PHONES AND PAGERS!TURN OFF CELL PHONES AND PAGERS! There will be a sign-in sheet circulated There will be a sign-in sheet circulated

during the meeting, which will be copied during the meeting, which will be copied for the sponsor.for the sponsor.

Stick to the agenda.Stick to the agenda.


The Meeting - 2The Meeting - 2 Manage the time well. Leave small talk to Manage the time well. Leave small talk to

the end, if there is time. the end, if there is time. Be brief and stay focused on scope of Be brief and stay focused on scope of

meeting.meeting. No side conversations.No side conversations. No open-ended questions.No open-ended questions. If the group gets bogged down on one issue, If the group gets bogged down on one issue,

suggest that the one issue be handled off-suggest that the one issue be handled off-line and continue with the other topics. line and continue with the other topics.

Ensure that at least one person from your Ensure that at least one person from your company is taking notes during the meeting. company is taking notes during the meeting.


The Meeting - 3The Meeting - 3

While taking notes, mark the items that are While taking notes, mark the items that are action itemsaction items, , – commitments for providing follow-up information commitments for providing follow-up information

to the companyto the company– commitments for providing follow-up information commitments for providing follow-up information

to the FDA, to the FDA, – arranging for off-line discussionsarranging for off-line discussions

Make sure there is about 10 minutes at the Make sure there is about 10 minutes at the end of the meeting to review the Action Item end of the meeting to review the Action Item list.list.

Get a copy of the attendees list.Get a copy of the attendees list.


Follow-Up After a Follow-Up After a Meeting with the FDAMeeting with the FDA


DebriefDebrief As soon as possible after the meeting, gather As soon as possible after the meeting, gather

the company representatives to debriefthe company representatives to debrief As part of the debriefing, get people’s As part of the debriefing, get people’s

perceptions of the reaction to the perceptions of the reaction to the presentation of each member of the FDA’s presentation of each member of the FDA’s TeamTeam– Assess if there may be any Assess if there may be any

misunderstandings or mistaken impressions misunderstandings or mistaken impressions by anyone – can expand upon some things by anyone – can expand upon some things in the minutes or add an addendum with in the minutes or add an addendum with clarificationclarification

– See if you may have “supporters” See if you may have “supporters”


Minutes of the MeetingMinutes of the Meeting

Have one person take everyone’s Have one person take everyone’s notes and draft the minutes, including notes and draft the minutes, including a section for the action itemsa section for the action items

Distribute to the other attendees for Distribute to the other attendees for review in order to ensure full capture review in order to ensure full capture of information, commitments, etc.of information, commitments, etc.

Issue minutes to managementIssue minutes to management Send to FDA with a cover letter asking Send to FDA with a cover letter asking

for commentsfor comments


Miscellaneous Miscellaneous InformationInformation


References - DrugsReferences - Drugs

CDER Data Standards Manual: Industry CDER Data Standards Manual: Industry Meetings Types Meetings Types http://www.fda.gov/cder/dsm/drg/Drg00917.htmhttp://www.fda.gov/cder/dsm/drg/Drg00917.htm

Formal meetings – PDUFA Products Formal meetings – PDUFA Products http://www.fda.gov/cder/gdlns/mtpdufa.htmhttp://www.fda.gov/cder/gdlns/mtpdufa.htm

Clinical Hold/Refusal to file Meetings Clinical Hold/Refusal to file Meetings http://www.fda.gov/cber/oversite/oversite.htmhttp://www.fda.gov/cber/oversite/oversite.htm

CMC IND Meetings CMC IND Meetings http://www.fda/gov/cber/gdlns/ind052501.htmhttp://www.fda/gov/cber/gdlns/ind052501.htm

The New Drug Approval Process The New Drug Approval Process http://www.fda/gov/cder/handbook/develop.htmhttp://www.fda/gov/cder/handbook/develop.htm


References - DevicesReferences - Devices

Early Collaboration Meetings under Early Collaboration Meetings under FDAMA - Meeting guidance FDAMA - Meeting guidance http://www.fda.gov/cdrh/ode/guidance/310.htmlhttp://www.fda.gov/cdrh/ode/guidance/310.html

Advisory Panel Meetings Advisory Panel Meetings http://www.fda.gov/modact/amendpan.hthttp://www.fda.gov/modact/amendpan.htmlml

Advisory Panel/Committee Information Advisory Panel/Committee Information Contact Contact http://fda.gov/cdrh/commline.htmlhttp://fda.gov/cdrh/commline.html

Feldman 13 Nov 2007 1 Meetings with FDA Martha A. Feldman, RAC Drug & Device Development Co., Inc....

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