Public Calendar: March 29 - April 4, 2020
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: Stephen M. Hahn, M.D., Commissioner of Food and Drugs
Event Date: 04/01/2020
Location: Teleconference
Subject: Meeting with Medical Device Leaders Regarding Ventilators
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Brian O'Connor, Chris White, Greg Crist, Janet Trunzo, Nancy Jackson, Scott Whitaker (AdvaMed); John Groetelaars (Hill-Rom); Gaurav Agarwal (Vyaire); Vitor Rocha (Philips); Michael Farrell (ResMed Corp); Jan Makela (Imaging); John Liddicoat (Medtronic);
Event Date: 04/02/2020
Location: Teleconference
Subject: Meeting with Pharmaceutical Research and Manufacturers of America (PhRMA) and Industry Research and Development Leaders on COVID-19 Therapeutics
FDA Participant/Group: Several FDA staff
Non FDA Participant/Group: Vas Narasimhan (Novartis); Jeff Jonas (Sage Therapeutics); Robert Scott (AbbVie); David Nicholson (Allergan); Stefan Oelrich (Bayer); Steve Benner (Astellas); James Mayne, James Stansel, Kelly Goldberg, Lucy Vereshchagina, Mary Kosinski, Richard Moscicki, Steve Ubl (PhRMA); Thomas Seck (Boehringer Ingelheim); Dave Ricks (Eli LIlly); Richard Pops (Alkermes); Giovanni Caforio (Bristol-Myers Squibb); Belen Garijo (EMD Serono); Jose Baselga, Pascal Soriot (AstraZeneca); Roger Perlmutter (Merck); Andrew Plump (Takeda); Mikael Dolsten (Pfizer); John Orloff (Alexion); John Reed (Sanofi); Samit Hirawat (Bristol-Meyers Squibb); Daniel Skovronsky (Eli Lilly); David Reese (Amgen); Mathai Mammen (Johnson & Johnson); Bernd Kieseier (Biogen); Levi Garraway (Genentech); Ivan Cheung (Eisai); Herve Hoppenot (Incyte);
Official Name: Amy Abernethy, M.D., Ph.D, Principal Deputy Commissioner
Event Date: 04/01/2020
Location: Virtual
Subject: Health Evolution: 2020 Executive Briefing on Artificial Intelligence (AI) & Machine Learning (ML)
FDA Participant/Group: N/A
Non FDA Participant/Group: Academics, industry, and other stakeholders
Event Date: 04/02/2020
Location: Virtual
Subject: Health Evolution: Pandemic Response - A Public-Private Call to Action
FDA Participant/Group: N/A
Non FDA Participant/Group: Industry, academics, government and other stakeholders
Official Name: Anand Shah, M.D., Deputy Commissioner for Medical and Scientific Affairs
No Significant Event
Official Name: Anna Abram, 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: Lowell Schiller, Principal Associate Commissioner for Policy
No Significant Event
Official Name: Mark Abdoo, Associate Commissioner for Global Policy and Strategy
No Significant Event
Official Name: Judy McMeekin, Acting Associate Commissioner for Regulatory Affairs
No Significant Event
Official Name: Laura Caliguiri, Associate Commissioner for External Affairs
No Significant Event
Official Name: RADM Denise Hinton, Chief Scientist
No Significant Event
Official Name: Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research
No Significant Event
Official Name: Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research
Event Date: 04/02/2020
Location: Virtual
Subject: Food and Drug Law Institute (FDLI) Webinar; Keynote Speaker: Regenerative Medicine Therapies
FDA Participant/Group: N/A
Non FDA Participant/Group: INdustry, government, and other stakeholders
Official Name: Jeffrey Shuren, M.D., J.D., Director, Center for Devices and Radiological Health
No Significant Event
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: Stacy Cline Amin, Chief Counsel
Event Date: 03/30/2020
Location: Virtual
Subject: Zofran Citizen Petition
FDA Participant/Group: SARA BEARDSLEY; KAREN SCHIFTER; JANICE WEINER; NICHOLAS BESHARA; ANNAMARIE KEMPIC; MEADOW PLATT; AMANDA EDMONDS; ELIZABETH JUNGMAN;
Non FDA Participant/Group: Tobi Milrood (Pogust Millrood LLC); Kimberly Baden, Louis Bograd (Motley Rice LLC); Kate Jaycox (Robins Kaplan LLP); Thomas Ayala (Grant & Eisenhofer); Robert Jenner (Jenner Law, P.C);