Ranking FDA Product Categories Based on Health Consequences, Phase II

Closed

July 20 - 21, 2010

Past

Additional Information

Is it a Closed Session event?

Institution Closed

The following committee members were present at the closed sessions of the event

Robert Lawrence (chair)
Francisco Diez-Gonzalez
Kathryn Edwards (via teleconference)
Susan Ellenberg
Paul Fischbeck
Karen Jenni
Helen Jensen
Robin Keller
David Meltzer
Sanford Miller
John Watson (via teleconference)

The following topics were discussed in the closed sessions:

1) Committee’s draft report
2) Conclusions and recommendations
3) Deadlines and schedule for report review

The following materials (written documents) were made available to the committee in the closed sessions:

11. FDA. 2010. Information requested from the committee on medical devices, received July 14, 2010.

Date of posting of Closed Session Summary:

July 26, 2010

Contact

Nola Golson

202-334-1669
pgolson@nas.edu

Location

Keck Center

500 5th St NW

Washington DC 20001, USA

Disclaimer

It is essential to the National Academies mission of providing evidence-based advice that participants in any of our meetings or events avoid political or partisan statements or commentary and maintain a culture of mutual respect. The statements and presentations during our meetings or events are solely those of the individual participants and do not necessarily represent the views of other participants or the National Academy of Sciences, which is a non-partisan, tax exempt organization that includes under its Charter the National Academy of Engineering and National Academy of Medicine, and that operates the National Research Council.

Closed

Ranking FDA Product Categories Based on Health Consequences, Phase II

June 22 - 23, 2010

Past

Additional Information

Is it a Closed Session event?

Institution Closed

The following committee members were present at the closed sessions of the event

Robert Lawrence (chair)
Francisco Diez-Gonzalez
Kathryn Edwards
Susan Ellenberg
Paul Fischbeck
Karen Jenni
Helen Jensen
Robin Keller
James McKean
David Meltzer
Sanford Miller
Richard Platt (via teleconference)
John Watson

The following topics were discussed in the closed sessions:

1) Draft materials developed by committee members.
2) Conclusions and recommendations.
3) Additional materials and information needed to finalize the draft report.
4) Meeting schedule and deadlines for committee assignments.

The following materials (written documents) were made available to the committee in the closed sessions:

FDA. 2010. Response to committee request for data. E-mail received from Kathleen Koehler on May, 13, 2010.

FDA. 2010. Response to committee request for data. E-mail with attachment received from Kathleen Koehler on May 25, 2010.

FDA. 2010. Response to committee request for data. E-mail received from Kathleen Koehler on June 1, 2010.

Date of posting of Closed Session Summary:

July 26, 2010

Contact

Nola Golson

202.334.1669
pgolson@nas.edu

Location

Keck Center

500 5th St NW

Washington DC 20001, USA

Disclaimer

It is essential to the National Academies mission of providing evidence-based advice that participants in any of our meetings or events avoid political or partisan statements or commentary and maintain a culture of mutual respect. The statements and presentations during our meetings or events are solely those of the individual participants and do not necessarily represent the views of other participants or the National Academy of Sciences, which is a non-partisan, tax exempt organization that includes under its Charter the National Academy of Engineering and National Academy of Medicine, and that operates the National Research Council.

Closed

Meeting 6

April 20 - 21, 2010

Past

Additional Information

Is it a Closed Session event?

Institution Closed

The following committee members were present at the closed sessions of the event

Robert Lawrence (chair)
Jeffrey Bender
Francisco Diez-Gonzalez
Kathryn Edwards
Susan Ellenberg
Paul Fischbeck
Karen Jenni
Helen Jensen
Robin Keller
James McKean
David Meltzer (via teleconference)
Sanford Miller
John Watson

The following topics were discussed in the closed sessions:

1) Draft materials developed by committee members.
2) Content and organization of the committee’s final report.
3) Preliminary conclusions and recommendations.
4) The schedule for committee meetings and deadlines for committee
assignments.

The following materials (written documents) were made available to the committee in the closed sessions:

None.

Date of posting of Closed Session Summary:

April 27, 2010

Contact

Heidi Murray-Smith

202-334-1434
hmurray-smith@nas.edu

Location

Keck Center

500 5th St NW

Washington DC 20001, USA

Disclaimer

It is essential to the National Academies mission of providing evidence-based advice that participants in any of our meetings or events avoid political or partisan statements or commentary and maintain a culture of mutual respect. The statements and presentations during our meetings or events are solely those of the individual participants and do not necessarily represent the views of other participants or the National Academy of Sciences, which is a non-partisan, tax exempt organization that includes under its Charter the National Academy of Engineering and National Academy of Medicine, and that operates the National Research Council.

Closed

Ranking FDA Product Categories Based on Health Consequences, Phase II

February 3 - 4, 2010

Past

Additional Information

Is it a Closed Session event?

Institution Closed

The following committee members were present at the closed sessions of the event

Robert Lawrence (chair)
Jeffrey Bender
Francisco Diez-Gonzalez
Kathryn Edwards
Susan Ellenberg
Paul Fischbeck
Karen Jenni
Helen Jensen
Robin Keller
Sanford Miller
John Watson (via teleconference)

The following topics were discussed in the closed sessions:

1) Scenarios provided by the U.S. Food and Drug Administration.
2) Information provided at the public session.
3) Content and organization of the committee’s final report.
4) The schedule for workshops and committee meetings.

The following materials (written documents) were made available to the committee in the closed sessions:

2. FDA. 2009. Public Health Risk/Benefit Decision Scenarios for the National Academy of Sciences Committee. December 3, 2009.

3. FDA. 2009. Public Health Risk/Benefit Decision Scenarios for the National Academy of Sciences Committee: Second Submission. December 16, 2009.

4. FDA. 2010. Public Health Risk/Benefit Decision Scenarios for the National Academy of Sciences Committee: Scenarios Relevant to Medical Devices. January 26, 2010.

5. FDA. 2010. Public Health Risk/Benefit Decision Scenarios for the National Academy of Sciences Committee: Comprehensive List. January 26, 2010.

6. FDA. 2010. Public Health Risk/Benefit Decision Scenarios for the National Academy of Sciences Committee: Final Submission. February 3, 2010.

7. FDA 2010. Opening Remarks by Malcolm J. Bertoni, Assistant Commissioner for Planning, U.S. Food and Drug Administration, at public session of Committee on Ranking FDA Product Categories Based on Health Consequences, Phase II. Washington, DC. February 3, 2010.

Date of posting of Closed Session Summary:

February 16, 2010

Contact

Nola Golson

202.334.1669
pgolson@gmail.com

Location

National Academy of Sciences Building

2101 Constitution Ave NW

Washington DC 20418, USA

Disclaimer

It is essential to the National Academies mission of providing evidence-based advice that participants in any of our meetings or events avoid political or partisan statements or commentary and maintain a culture of mutual respect. The statements and presentations during our meetings or events are solely those of the individual participants and do not necessarily represent the views of other participants or the National Academy of Sciences, which is a non-partisan, tax exempt organization that includes under its Charter the National Academy of Engineering and National Academy of Medicine, and that operates the National Research Council.

Closed

Ranking FDA Product Categories Based on Health Consequences, Phase II - Teleconference

December 21, 2009

12:00 AM - 12:00 AM (EST)

Past

Additional Information

Is it a Closed Session event?

Institution Closed

The following committee members were present at the closed sessions of the event

Robert Lawrence (chair), Jeffrey Bender, Kathryn Edwards, Paul Fischbeck, Karen Jenni, Helen Jensen, Robin Keller, James McKean, David Meltzer, Sanford Miller, Richard Platt and John Watson.

The following topics were discussed in the closed sessions:

1. Scenarios provided to the committee by FDA.
2. Agenda for February committee meeting.
3. Action items and committee assignments.

The following materials (written documents) were made available to the committee in the closed sessions:

2. FDA. 2009. Public Health Risk/Benefit Decision Scenarios for the National Academy of Sciences Committee. December 3, 2009.

3. FDA. 2009. Public Health Risk/Benefit Decision Scenarios for the National Academy of Sciences Committee: Second Submission. December 16, 2009.

Date of posting of Closed Session Summary:

January 07, 2010

Contact

Panola Golson

(202) 334-1669
pgolson@nas.edu

Location

Keck Center

500 5th St NW

Washington DC 20001, USA

Disclaimer

It is essential to the National Academies mission of providing evidence-based advice that participants in any of our meetings or events avoid political or partisan statements or commentary and maintain a culture of mutual respect. The statements and presentations during our meetings or events are solely those of the individual participants and do not necessarily represent the views of other participants or the National Academy of Sciences, which is a non-partisan, tax exempt organization that includes under its Charter the National Academy of Engineering and National Academy of Medicine, and that operates the National Research Council.

Closed

Ranking FDA Product Categories Based on Health Consequences, Phase II - Conference Call

October 29, 2009

12:00 AM - 12:00 AM (EDT)

Past

Additional Information

Is it a Closed Session event?

Institution Closed

The following committee members were present at the closed sessions of the event

Robert Lawrence (Chair)
Jeffrey Bender
Kathryn Edwards
Susan Ellenberg
Paul Fischbeck
Karen Jenni
Helen Jensen
Robin Keller
Sanford Miller
John Watson

The following topics were discussed in the closed sessions:

1) Revisions to the committee’s statement of task.
2) Agenda for February workshop.
3) Action items and committee assignments.

The following materials (written documents) were made available to the committee in the closed sessions:

None.

Date of posting of Closed Session Summary:

November 10, 2009

Contact

Nola Golson

202-334-1669
pgolson@gmail.com

Location

Keck Center

500 5th St NW

Washington DC 20001, USA

Disclaimer

It is essential to the National Academies mission of providing evidence-based advice that participants in any of our meetings or events avoid political or partisan statements or commentary and maintain a culture of mutual respect. The statements and presentations during our meetings or events are solely those of the individual participants and do not necessarily represent the views of other participants or the National Academy of Sciences, which is a non-partisan, tax exempt organization that includes under its Charter the National Academy of Engineering and National Academy of Medicine, and that operates the National Research Council.

Closed

Ranking FDA Product Categories Based on Health Consequences, Phase II

June 24 - 25, 2009

Past

Additional Information

Is it a Closed Session event?

Institution Closed

The following committee members were present at the closed sessions of the event

Robert Lawrence (chair)
Jeffrey Bender
Francisco Diez-Gonzalez
Kathryn Edwards
Susan Ellenberg
Paul Fischbeck
Karen Jenni
Helen Jensen
Robin Keller
James McKean
David Meltzer
Sanford Miller
Richard Platt (via teleconference)
John Watson

The following topics were discussed in the closed sessions:

1) Components of the committee’s risk-ranking model (product categories and risk attributes).
2) Structure of committee workshops to conduct risk-ranking exercise.
3) Content and organization of the committee’s final report.
4) The schedule for workshops and committee meetings.

The following materials (written documents) were made available to the committee in the closed sessions:

None.

Date of posting of Closed Session Summary:

June 30, 2009

Contact

Nola Golson

202-334-1669
pgolson@nas.edu

Location

Keck Center

500 5th St NW

Washington DC 20001, USA

Disclaimer

It is essential to the National Academies mission of providing evidence-based advice that participants in any of our meetings or events avoid political or partisan statements or commentary and maintain a culture of mutual respect. The statements and presentations during our meetings or events are solely those of the individual participants and do not necessarily represent the views of other participants or the National Academy of Sciences, which is a non-partisan, tax exempt organization that includes under its Charter the National Academy of Engineering and National Academy of Medicine, and that operates the National Research Council.

Closed

Meeting 1

April 6 - 7, 2009

Past

Additional Information

Is it a Closed Session event?

Institution Closed

The following committee members were present at the closed sessions of the event

Robert Lawrence (chair)
Jeffrey Bender (via teleconference)
Francisco Diez-Gonzalez
Kathryn Edwards
Susan Ellenberg
Paul Fischbeck
Karen Jenni (via teleconference)
Helen Jensen
Robin Keller
James McKean
David Meltzer (via teleconference)
Sanford Miller
Richard Platt (via teleconference)
John Watson

The following topics were discussed in the closed sessions:

1) Standard NRC discussion of policies, procedures, potential bias and conflict of interest.

2) Committee’s statement of task, approach, and letter report.

3) Agenda for Workshop I at which product categories and risk attributes will be finalized.

4) Schedule for future committee meetings.

The following materials (written documents) were made available to the committee in the closed sessions:

1. FDA. 2009. FDA Comments on NAS “Letter Report on the Development of a Model for Ranking FDA Product Categories on the Basis of Health Risks.” April 3, 2009.

Date of posting of Closed Session Summary:

April 16, 2009

Contact

Nola Golson

202-334-1669
pgolson@nas.edu

Location

Keck Center

500 5th St NW

Washington DC 20001, USA

Disclaimer

It is essential to the National Academies mission of providing evidence-based advice that participants in any of our meetings or events avoid political or partisan statements or commentary and maintain a culture of mutual respect. The statements and presentations during our meetings or events are solely those of the individual participants and do not necessarily represent the views of other participants or the National Academy of Sciences, which is a non-partisan, tax exempt organization that includes under its Charter the National Academy of Engineering and National Academy of Medicine, and that operates the National Research Council.

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Ranking FDA Product Categories Based on Health Consequences, Phase II

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