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  5. Public Calendar: August 8-14, 2021
  1. Public Calendar - Meetings With FDA Officials

Public Calendar: August 8-14, 2021

This public calendar is issued by the Food and Drug Administration. It lists significant meetings held by designated FDA policy makers with persons outside the executive branch of the federal government.

Official Name: Janet Woodcock, M.D., Acting Commissioner

Event Date: 08/11/2021
Location: Virtual
Subject: Trial Updates and Protocols
FDA Participant/Group: PETER STEIN;
Non FDA Participant/Group: Parties involved in Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV)

Official Name: Andi Lipstein Fristedt, Deputy Commissioner for Policy, Legislation, and International Affairs

No Significant Event

Official Name: Jim Sigg, Deputy Commissioner for Operations

No Significant Event

Official Name: Frank Yiannas, Deputy Commissioner for Food Policy and Response

No Significant Event

Official Name: Mark Abdoo, Associate Commissioner for Global Policy and Strategy

No Significant Event

Official Name: Judy McMeekin, Associate Commissioner for Regulatory Affairs

No Significant Event

Official Name: Erica Jefferson, Associate Commissioner for External Affairs

No Significant Event

Official Name: RADM Denise Hinton, Chief Scientist

No Significant Event

Official Name: Patrizia Cavazzoni, M.D., Director, Center for Drug Evaluation and Research

Event Date: 08/10/2021
Location: Virtual
Subject: Center for Drug Evaluation and Reserch (CDER) and U.S. Army Medical Research and Development Command (USAMRDC) Partnership Meeting
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Several representatives from USAMRDC

Official Name: Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research

Event Date: 08/13/2021
Location: Virtual
Subject: Panelist: What Additional Research is Needed to Support Informed Regulatory Decision-making About the Benefits and Risks of Booster Doses?
FDA Participant/Group: PHILIP KRAUSE;
Non FDA Participant/Group: Attendees of the World Health Organization (WHO) Research and Development (R&D) Blueprint Consultation on COVID-19 Vaccines Research

Event Date: 08/14/2021
Location: Virtual
Subject: Speaker: FDA Update Regarding Additional Vaccine Doses for Immunocompromised Individuals
FDA Participant/Group: N/A
Non FDA Participant/Group: Attendees of the Centers for Disease Control and Prevention (CDC)/ Infectious Diseases Society of America (IDSA) COVID-19 Clinician Call

Official Name: Jeffrey Shuren, M.D., J.D., Director, Center for Devices and Radiological Health

Event Date: 08/10/2021
Location: Virtual
Subject: General Medical Device Issues and Updates Meeting
FDA Participant/Group: BLETA VUNIQI; MARIANELA PEREZ-TORRES; OWEN FARIS; CAROLYN DORGAN; ERIN KEITH; FRANCISCO VICENTY; KELLIE KELM; COURTNEY LIAS;
Non FDA Participant/Group: Tom Polen, Beth McCombs, David Shan, William Sigmund, Ami Simunovich, Brad Spring, Mark O’Donnell, Adrienne Brott (Becton, Dickinson and Company)

Official Name: Susan T. Mayne, Ph.D., Director, Center for Food Safety and Applied Nutrition

No Significant Event

Official Name: Mitchell R. Zeller, J.D., Director, Center for Tobacco Products

No Significant Event

Official Name: Steven Solomon, Director, Center for Veterinary Medicine

Event Date: 08/13/2021
Location: Virtual
Subject: Veterinary Issues of Mutual Interest
FDA Participant/Group: ANNE NORRIS; NADINE STEINBERG; WILLIAM FLYNN; CINDY BURNSTEEL; SUSAN BRIGHT-PONTE; SHANNON RUTHERFORD; ASHLEY STEEL; SIOBHAN DELANCEY; ANTONIA MONIQUE SENNETT; PATRICK MCDERMOTT; AMBER MCCOIG; NEAL BATALLER;
Non FDA Participant/Group: Representatives of The Pew Charitable Trusts

Official Name: William Slikker, Jr., Ph.D., Director, National Center for Toxicological Research

No Significant Event

Official Name: Mark Raza, J.D., Acting Chief Counsel

Event Date: 08/11/2021
Location: Virtual
Subject: Heron Therapeutis Marketing Plan
FDA Participant/Group: ELIZABETH DICKINSON; AMANDA SUTARIA; DEBORAH CHASAN SLOAN; KAREN SCHIFTER; AMANDA EDMONDS; ANN OXENHAM; ANNAMARIE KEMPIC;
Non FDA Participant/Group: Barry Quart, Chris Storgard, David Szekeres, John Poyhonen, Kimberly Manhard, Mike Mathews (Heron Therapeutics); Jeff Bucholtz , Sheldon Bradshaw (King & Spalding);

 

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