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Remarks by Frank Yiannas on World Food Safety Day 2021 at National Environmental Health Association/Environmental Health Australia Event - 06/07/2021
… all over the world safe and healthy. As we’ve learned from COVID-19, infectious diseases know no borders. The same is true of … . As nations continue to combat the danger that is COVID-19, the hope and commitment embodied in World Food …
POSTPONED- Vaccines and Related Biological Products Advisory Committee February 15, 2022 Meeting Announcement - 02/15/2022
… … Vaccines … THIS MEETING IS POSTPONED. Coronavirus (COVID-19) Update: FDA Postpones Advisory Committee Meeting to Discuss Request for Authorization of Pfizer-BioNTech COVID-19 Vaccine for Children 6 Months Through 4 Years of Age …
Dr. Hahn's Remarks to the Intergovernmental Working Meeting on Drug Compounding - 10/27/2020
… ever in light of the enormous challenges presented by the COVID-19 pandemic. During this pandemic, acute shortages of drugs … drug supply interruptions and other challenges related to COVID-19. As everyone here recognizes, compounded drugs serve …
Remarks by Dr. Janet Woodcock to the 2021 Rx Drug Abuse and Heroin Summit - 04/08/2021
… in our work to overcome this enduring crisis. Impact of COVID As you know, this past year has presented some … by the opioid crisis, the impact and experiences of COVID-19 may sound all too familiar. The opioid crisis has …
Remarks by Acting Commissioner Woodcock to the Association for Accessible Medicines 2021Access! Conference - 05/26/2021
… We’ve made important strides in our efforts to combat COVID-19, although we still have a way to go. I’m extremely proud … has access to vaccines and other products to respond to COVID. The Importance of Access Let me just repeat those last …
Preparing for the Next Public Health Emergency: Reauthorizing the Pandemic and All-Hazards Preparedness Act - 05/04/2023
… All Hazards Preparedness Act. The last three years of the COVID-19 pandemic underscore the need to continue to optimize our … to, public health emergencies and disease threats such as COVID-19, mpox, respiratory syncytial virus, and pandemic …
Remarks by Dr. Woodcock at the FDA FY 2021 Generic Drug Science and Research Initiatives Public Workshop - 06/23/2021
… forward to that day soon. For well over a year now, the COVID-19 pandemic has dominated our personal and professional … to implement new systems and processes to respond to the COVID-19 public health emergency, while continuing to meet …
November 30, 2021: Antimicrobial Drugs Advisory Committee Meeting Announcement - 11/30/2021
… Eastern Time Please note that due to the impact of this COVID-19 pandemic, all meeting participants will be joining this … oral capsules for treatment of mild to moderate COVID-19 in adults who are at risk for progressing to severe …
2023 FDA Digital Transformation Symposium - 12/04/2023
… information, please contact ODT-Events@fda.hhs.gov . COVID-19 Information for FDA and panelists attending in person: The CDC COVID-19 Hospital Admission Level Website offers individual …
NOTICE OF MEETING POSTPONEMENT: June 9, 2020 - Ophthalmic Devices Panel of the Medical Devices Advisory Committee - 06/09/2020 - 06/09/2020
… event that our day-to-day operations are impacted by the COVID-19 public health emergency. Therefore, we are postponing … while our day-to-day operations are impacted by the COVID-19 public health emergency, and we have decided to …
FDA Oncology Center of Excellence Presents: Conversation on Cancer: Advancing Equity in Asian American and Pacific Islander (AAPI) Communities: Racism and Injustice - 07/29/2021 - 07/29/2021
… often linked to rhetoric blaming AAPIs for the spread of COVID-19. This is an important problem affecting many AAPI … informal and will address the following topics: Impact of COVID-19 on racism and healthcare in the AAPI population …
Vaccines and Related Biological Products Advisory Committee October 14-15, 2021 Meeting Announcement - 10/14/2021
… … Please note that due to the impact of this COVID-19 pandemic, all meeting participants will be joining this … Emergency Use Authorization (EUA) of the ModernaTX Inc. COVID-19 vaccine for the administration of an additional …
Vaccines and Related Biological Products Advisory Committee February 26, 2021 Meeting Announcement - 02/26/2021
… … Please note that due to the impact of this COVID-19 pandemic, all meeting participants will be joining this … in open session to discuss EUA of the Janssen Biotech Inc. COVID-19 Vaccine for active immunization to prevent COVID-19 …
Vaccines and Related Biological Products Advisory Committee December 10, 2020 Meeting Announcement - 12/10/2020
… … Please note that due to the impact of this COVID-19 pandemic, all meeting participants will be joining this … Emergency Use Authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 in …
Vaccines and Related Biological Products Advisory Committee December 17, 2020 Meeting Announcement - 12/17/2020
… … Please note that due to the impact of this COVID-19 pandemic, all meeting participants will be joining this … Emergency Use Authorization (EUA) of the Moderna, Inc., COVID-19 Vaccine for the prevention of COVID-19 in …
Remarks by Commissioner Robert Califf to the Healthcare Distribution Alliance Board of Directors meeting - 11/15/2023
… illnesses, including RSV, the flu, and the ongoing Covid pandemic. This is just one example of how vulnerable to … The impact of this gap is clear. Now that the COVID-19 PHE has ended, manufacturers are no longer providing …
Regulatory Education for Industry (REdI) Annual Conference 2022 - 06/06/2022
… enter the 3rd year of FDA’s public health response to the COVID-19 pandemic, this plenary session will reflect on some of … look ahead at FDA’s future activities in the fight against COVID-19 and beyond. An emergency use authorization, or EUA, …
Vaccines and Related Biological Products Advisory Committee June 7, 2022 Meeting Announcement - 06/07/2022
… … Vaccines … Please note that due to the impact of the COVID-19 pandemic, all meeting participants will be joining this … (EUA) request by Novavax for a vaccine to prevent COVID-19 in individuals 18 years of age and older. Meeting …
Vaccines and Related Biological Products Advisory Committee June 28, 2022 Meeting Announcement - 06/28/2022
… … Vaccines … Please note that due to the impact of the COVID-19 pandemic, all meeting participants will be joining this … whether and how the SARS-CoV-2 strain composition of COVID-19 vaccines should be modified.. Meeting Materials FDA …
Vaccines and Related Biological Products Advisory Committee January 26, 2023 Meeting Announcement - 01/26/2023
… … Please note that due to the impact of the COVID-19 pandemic, all meeting participants will be joining this … to discuss the future vaccination regimens addressing COVID-19. Meeting Materials FDA intends to make background …
Public Meeting: FDA Rare Disease Day 2021 - 03/05/2021 - 03/05/2021
… to support rare disease product development during the COVID-19 pandemic, and current perspectives on rare disease product … to support rare disease product development during COVID-19. This public meeting will consist of presentations …
SARS-CoV-2: Host-pathogen interaction, vaccines & variants of concern - 07/08/2021 - 07/08/2021
… focus of his work is on SARS-CoV-2 (the caustive agent of COVID-19). Because of his coronavirus experience he is a co-opted … infection which will help in future treatments of COVID-19 patients. They will also present results on the …
Remarks by Frank Yiannas at the International Association for Food Protection 2020 Annual Meeting - 10/27/2020
… and the agency’s focus had to turn, rightfully so, to our COVID response. However, while we were dealing with COVID we had staff working behind the scenes on New Era and … and for all bend the curve of foodborne illness. COVID-19 But first, I’d like to pause and acknowledge the role that …
Remarks by Acting Commissioner Janet Woodcock to the 2021 GRx+Biosims Conference - 11/08/2021
… This has been especially important over the past 19 months, as we have taken on enormous additional responsibilities responding to the COVID-19 public health emergency. Our work to expand … the effort to find treatments and cures in response to the COVID-19 pandemic. These efforts also support another …
Model Informed Drug Development Approaches for Immunogenicity Assessments - 06/09/2021 - 06/09/2021
… Immune Receptor Data Session 3 Yongqun He, Ph.D. – COVID-19 Vaccine Machine Learning, Ontology Modeling, and … Vaccine Dose Ryoko Sawamura, PhD. – QSP Application to COVID-19 Vaccine Clinical Development Session 4 Guangping …