Public Calendar: April 4-10, 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: 04/05/2021
Location: Virtual
Subject: COVID-19 Pandemic and Lessons Learned for the Future of Clinical Trials
FDA Participant/Group: DAYLE CRISTINZIO;
Non FDA Participant/Group: Several members of the Longwood Healthcare Leaders, academia, government and other invited guests

Event Date: 04/06/2021
Location: Virtual
Subject: Listening Session with the ALS Association
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Jinsy Andrews (The ALS Association Board of Trustees); Calaneet Balas (The ALS Association);

Event Date: 04/07/2021
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)

Event Date: 04/08/2021
Location: Virtual
Subject: American Public Health Association Policy Action Institute; Panelist: COVID-19 - An Update
FDA Participant/Group: DAYLE CRISTINZIO;
Non FDA Participant/Group: Academia, industry, government, media and other registered guests

Event Date: 04/09/2021
Location: Virtual
Subject: COVID-19 Vaccine Process
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Several members from Vaccinate Your Family and Healthcare Stakeholder Groups

Event Date: 04/09/2021
Location: Virtual
Subject: American Society of Clinical Oncologists (ASCO); Speaker: Modernizing Eligibility Criteria in Clinical Trials: How We Can Improve Patient Access and Representation
FDA Participant/Group: JULIA BEAVER; DAYLE CRISTINZIO;
Non FDA Participant/Group: Academia, industry, government, media and other registered guests

Official Name: Amy Abernethy, M.D., Ph.D., Principal Deputy Commissioner

Event Date: 04/08/2021
Location: Virtual
Subject: Clinical Trials Transformation Initiative (CTTI) Executive Think Tank Meeting
FDA Participant/Group: BAKUL PATEL;
Non FDA Participant/Group: Academia, industry, and other stakeholders

Event Date: 04/08/2021
Location: Virtual
Subject: Pharma: Clinical 2021 Conference; Speaker: Direct from the FDA: Guidance on Diversity, Implementation, and Real World Data (RWD) Integration
FDA Participant/Group: LAURA ROE;
Non FDA Participant/Group: Academia, industry, and other stakeholders

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

Event Date: 04/06/2021
Location: Virtual
Subject: Leafy Greens Issues of Mutual Interest
FDA Participant/Group: JEFFREY FARRAR;
Non FDA Participant/Group: Karen Ross, Natalie Krout (California Department of Food and Agriculture);

Event Date: 04/08/2021
Location: Virtual
Subject: Safe Food Coalition Meeting
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Several executives from across the consumer associations, scientific and technical staff from industry

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

No Significant Event

Official Name: Judy McMeekin, Associate Commissioner for Regulatory Affairs

Significant Event

Official Name: Heidi Rebello, Acting Associate Commissioner for External Affairs

No Significant Event

Official Name: RADM Denise Hinton, Chief Scientist

No Significant Event

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

Event Date: 04/06/2021
Location: Virtual
Subject: Margolis Alzheimer's Meeting
FDA Participant/Group: MICHELLE CAMPBELL;
Non FDA Participant/Group: Adam Kroetsch, Marianne Hamilton Lopez, Mark McClellan, Susan LaMacchia (Duke Margolis);

Event Date: 04/09/2021
Location: Virtual
Subject: National Niemann-Pick Disease Foundation Listening Session
FDA Participant/Group: PETER STEIN; SHAWN BROOKS; KATHLEEN DONOHUE; KERRY LEE; SADHNA KHATRI; JANET MAYNARD; CHRISTOPHER MELTON;
Non FDA Participant/Group: Representatives from the National Niemann-Pick Disease Foundation (NNPDF)

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

Event Date: 04/07/2021
Location: Virtual
Subject: Arizona Osteopathic Medical Association’s 99th Annual Convention; Speaker: Vaccine Development During the COVID-19 Pandemic
FDA Participant/Group: N/A
Non FDA Participant/Group: Industry, academia, other stakeholders, and invited guests

Event Date: 04/09/2021
Location: Virtual
Subject: Alpha-1 Foundation’s 22nd Gordon L. Snider Critical Issues Workshop; Speaker: The Regulatory Approach to Rare and Orphan Diseases
FDA Participant/Group: N/A
Non FDA Participant/Group: Industry, academia, other stakeholders, and invited guests

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

Event Date: 04/06/2021
Location: Virtual
Subject: Regulatory Issues
FDA Participant/Group: JENNIFER TOMASELLO; BRITTANY CALDWELL;
Non FDA Participant/Group: Jeff Allen (Friends of Cancer Research);

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

No Significant Event

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

No Significant Event