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Remarks by Commissioner Stephen Hahn, M.D. — The COVID-19 Pandemic — Finding Solutions, Applying Lessons Learned - 06/01/2020
… speeches-fda-officials/remarks-commissioner-stephen-hahn-md-covid-19-pandemic-finding-solutions-applying-lessons-learned … The COVID-19 Pandemic — Finding Solutions, Applying Lessons …
Hearing on an Emerging Disease Threat: How the U.S. Is Responding to COVID-19, the Novel Coronavirus - 03/03/2020 -
… testimony/hearing-emerging-disease-threat-how-us-responding-covid-19-novel-coronavirus-03032020 … Witness appearing before … there has been an increase in cases outside of China. COVID-19 is a new disease, caused by a novel (or new) …
COVID-19 and Beyond: Oversight of the FDA's Foreign Drug Manufacturing Inspection Process - 06/02/2020
… issues, it quickly acts to protect Americans. During the COVID-19 pandemic, FDA is continuing to utilize and implement … who can permanently attach to a foreign office. COVID-19 and Inspection Impact As noted at the beginning of …
An Update on the Ongoing Federal Response to COVID-19: Current Status and Future Planning - 06/16/2022
… nts/congressional-testimony/update-ongoing-federal-response-covid-19-current-status-and-future-planning-06162022 … INTRODUCTION … (FDA’s or the Agency’s) coronavirus disease 2019 (COVID-19) response efforts. All of our efforts are in close …
FDA Oncology Center of Excellence: Conversations on Cancer: Panel Discussion, “365 Days and Counting: COVID’s Impact on the Oncology Community” - 03/12/2021 - 03/12/2021
… Nurse III, City of Hope Background: Over the past year, COVID-19 has changed life as we know it. No one knows this better … Oncology Center of Excellence panel discussion about how COVID-19 has impacted every aspect of cancer care, from the …
FDA/CTTI Meeting on Mitigating Clinical Study Disruptions During Disasters and Public Health Emergencies - 10/18/2023
… is convening a virtual public meeting on October 18-19, 2023, to discuss recommendations provided by FDA during the COVID-19 public health emergency to mitigate disruption of … Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency, Guidance for Industry, …
FDA | CTTI Meeting on Mitigating Clinical Study Disruptions During Disasters and Public Health Emergencies - 10/18/2023
… is convening a virtual public meeting on October 18-19, 2023, to discuss recommendations provided by FDA during the COVID-19 public health emergency to mitigate disruption of … Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency, Guidance for Industry, …
Studies of SARS-CoV-2 NSP1 and Envelope Protein - 03/11/2021 - 03/11/2021
… Microbiology at NCTR. About the Presentation: To elucidate COVID-19 pathogenesis and develop a successful treatment will … Recording … Office of the Commissioner … To elucidate COVID-19 pathogenesis and develop a successful treatment will …
Remarks by FDA Chief Scientist Denise Hinton to the Professional Services Council FedHealth Conference - 03/11/2021
… resonance as we search for treatments to new diseases like COVID-19 in which certain segments of the population, including … of this pandemic to gain greater understanding of COVID-19, and to support the development of treatments and …
Dr. Hahn's remarks to the Alliance for Health Policy Brazda Breakfast Briefing - 01/08/2021
… in the form of scientific advances to help bring the COVID-19 pandemic under control. Over the past year, our nation has … significantly to meet the extraordinary demands of COVID-19, and our workforce responded in kind, taking on …
Remarks by Dr. Hahn to the FDA-CMS Summit - 12/07/2020
… conference title accurately captures, in the midst of “the COVID era.” As sister organizations under the HHS umbrella, … of this pandemic to help gain greater understanding of COVID-19. I am extremely proud of the hard work demonstrated by …
FDA User Fee Reauthorization: Ensuring Safe and Effective Medical Devices - 04/01/2022
… to shoulder the unprecedented demands of the global COVID-19 pandemic, where the demand for medical devices has far … likewise placed additional strain on the devices program. COVID-19 Pandemic It is hard to overstate the impact the …
Dr. Hahn's Remarks to the GRx+Biosims 2020 Virtual Conference - 11/09/2020
… Even as we have been working full steam on the response to COVID-19, our centers and offices have continued to fulfill the … treatments and supportive therapies for patients with COVID-19. We’ve done this while evaluating products based on …
Remarks for the Global Pharmaceutical Manufacturing Leadership Forum - 11/01/2020
… I was asked to speak on today – “Lessons Learned from COVID” – underscores the twofold approach we must embrace in … One way we’ve sought to support this effort is with the COVID-19 Pandemic Recovery and Preparedness Plan – we call it PREPP …
Remarks by Dr. Woodcock to the Regulatory Education for Industry Conference - 07/19/2021
… (EUAs) for the Pfizer-BioNTech, Moderna, and Janssen COVID-19 vaccines, and then working to expand that EUA access to … drops in the rate of infections and deaths from COVID-19. You’ll hear more about the process surrounding …
The Global Economy of FDA-Regulated Products Under Stress - 10/06/2020
… a global problem requires a global solution, and since the COVID-19 pandemic began, these partnerships have gone from … global regulatory partners. II. European Cooperation COVID-19 The outbreak of the novel coronavirus hasn’t just …
Commissioner Hahn's remarks to the 2020 FDLI Annual Conference - 10/06/2020
… in its continuing efforts not only to address the COVID-19 public health crisis, but why it is so successful in times … multi-faceted, super-accelerated response to COVID-19 – an effort that essentially has involved a doubling …
Clinical Investigator Training Course (CITC) Update - 12/07/2021
… 2 Innovations in the Design of Clinical Trials in Oncology COVID-19 Treatment Question and Answer Session Trial Populations – … Investigator Responsibilities Including as Applied during COVID-19 Question and Answer Session Wrap Up Cynthia …
Manufacturing, Supply Chain, and Inspections during the COVID19 Public Health Emergency - 08/25/2021 - 08/25/2021
… Speakers Part 1 FDA guidance on manufacturing during COVID-19 and high absenteeism Questions and Panel Discussion CDR … Slides TOPICS FDA guidance on manufacturing during COVID-19 and high absenteeism Risk management and application …
Dr. Hahn's Remarks to the 2020 NORD Rare Disease Summit - 10/08/2020
… patients with rare diseases, particularly during the COVID-19 pandemic. I especially want to recognize and thank the … we find ourselves in right now, are far from that. The COVID-19 pandemic has had far-reaching effects, and patients …
Dr. Hahn’s Remarks to the Meeting of the Regulatory Affairs Professionals Society (RAPS) - 11/17/2020
… public, the FDA has been engaged in combatting the COVID-19 pandemic for nearly nine months now. At times, it has … and availability of medical countermeasures to combat COVID-19. It has, in effect, doubled the agency’s workload. …
Remarks by Dr. Hahn to the Global Coalition for Regulatory Science Research - 09/30/2020
… the current public health emergency we are dealing with. COVID-19 has created unprecedented challenges affecting all sectors … But while we are faced with the reality of the COVID-19 pandemic right now, it also underscores the reality …
Dr. Hahn's remarks to the National Consumers League on the vaccine review process - 09/29/2020
… to you about the FDA's continuing efforts to address the COVID-19 public health crisis, and to focus on one aspect that I … have done remarkable work, not only in responding to the COVID-19 pandemic, but also in continuing to fulfill the …
Dr. Hahn's opening remarks at the MDUFA Public Meeting - 10/27/2020
… but because of the FDA’s vital role in responding to the COVID-19 public health emergency. So, before I turn to the … ago the FDA staff had their worlds turned upside down by COVID-19. Since then, they have faced significant challenges …
FDA Presentation: American Public Health Association's 2020 Virtual Annual Meeting - 10/26/2020
… On the Front Lines of Health Diplomacy During the Time of COVID-19 Hello, and thanks Matt for that introduction - it’s an … to talk about our foreign offices and the impact of COVID-19 on operations. I’m Bruce Ross, director of FDA’s …