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Public Workshop on COVID-19 Lessons Learned: Clinical Evaluation of Therapeutics - 09/28/2021
… /drugs/news-events-human-drugs/public-workshop-covid-19-lessons-learned-clinical-evaluation-therapeutics-09282021 … workshop is to share lessons learned from the Federal COVID-19 Response or Countermeasures Acceleration Groups (formerly …
SBIA Webinar: Conducting Clinical Trials During the COVID-19 Public Health Emergency - 04/30/2020 - 04/30/2020
… -human-drugs/sbia-webinar-conducting-clinical-trials-during-covid-19-public-health-emergency-04302020-04302020 … View Recording … View Slides ABOUT THIS WEBINAR FDA recognizes that the COVID-19 public health emergency may impact the conduct of …
Reunión pública sobre el desarrollo de medicamentos centrados en el paciente contra el COVID-19 persistente - 04/25/2023
… sarrollo-de-medicamentos-centrados-en-el-paciente-contra-el-covid-19 … English Información sobre la reunión Fecha: April 25, … de medicamentos centrados en el paciente contra el COVID-19 persistente. Esta reunión brindará a la FDA la …
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, …
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 …
Advancing Generic Drug Development: Translating Science to Approval - 09/21/2021
… of Food and Drugs Food and Drug Administration COVID-19 Impact on Generic Drug Regulation and Evaluation … Studies for Abbreviated New Drug Applications During the COVID-19 Public Health Emergency Alternative Bioequivalence …
Regulatory Education for Industry (REdI) Annual Conference 2021 - 07/19/2021 - 07/23/2021
… Office of New Drugs (OND) | CDER ANDA Efforts Related to COVID-19 John Ibrahim, PharmD Associate Director for Regulatory … Address Potential Medication Errors for EUA Products for COVID-19 Sevan Kolejian, PharmD, MBA, BCPPS Team Leader …
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 …
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, …
Pharmaceutical Quality Symposium 2021: Innovations in a Changing World - 10/26/2021
… world. Speakers will: Share lessons learned from the COVID-19 public health emergency. Describe recent regulatory … of pharmaceuticals. TOPICS COVERED Learning From the COVID-19 Public Health Emergency, including a panel …
UPDATED AGENDA AND PUBLIC PARTICIPATION INFORMATION: November 9, 2022 Meeting of the Pulmonary-Allergy Drugs Advisory Committee Meeting Announcement - 11/09/2022
… … UPDATED INFORMATION (as of October 19, 2022): UPDATED AGENDA AND PUBLIC PARTICIPATION … infection in hospitalized patients with moderate to severe COVID-19 infection who are at high risk of acute respiratory … Location CDER Please note that due to the impact of this COVID-19 pandemic, all meeting participants will be joining …
February 15, 2022: Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee - 02/15/2022
… Eastern Time Please note that due to the impact of this COVID-19 pandemic, all meeting participants will be joining this … Eastern Time Please note that due to the impact of this COVID-19 pandemic, all meeting participants will be joining …
2021 Scientific Computing Days - 09/22/2021 - 09/23/2021
… Approaches to Rapidly Address Drug Development Need: COVID-19 and Beyond ( Nadya Tarasova, PhD – NIH ) Reliable in … Data Integration Project ( Kevin Snyder, PhD – CDER ) COVID-19 Re-Opening Dashboard Project ( Nathan Beck, MS – OC …
14th Annual Sentinel Initiative Public Workshop - 11/15/2022
… to protect and promote public health during the ongoing COVID-19 pandemic and emerging monkeypox public health emergency. …
OTC Monograph Reform in the CARES Act: Safety Orders - 01/27/2021 - 01/27/2021
… in the CARES Act FDA STATEMENT - FDA on Signing of the COVID-19 Emergency Relief Bill, Including Landmark Over-the-Counter …
FDA, MHRA, and Health Canada Good Clinical Practice Workshop: Global Clinical Trials - Considerations and Lessons Learned from the Changing Landscape (2022) - 03/07/2022
… trials Updates in guidance and inspection approaches The COVID-19 pandemic has necessitated flexibility in clinical trial …
OTC Monograph Reform: Deemed Final Orders - 12/15/2021 - 12/15/2021
… Monograph Reform in the CARES Act FDA on Signing of the COVID-19 Emergency Relief Bill, Including Landmark Over-the-Counter …
FDA | United States Pharmacopeia (USP) Asia-Pacific Economic Cooperation (APEC) Medical Product Supply Chain Dialogue - 04/25/2023
… to discuss public health priorities, the impact of the COVID-19 pandemic on supply chains, and why the APEC Supply Chain …
OTC Monograph Reform: OTC Sunscreen Drugs - 12/15/2021 - 12/15/2021
… Monograph Reform in the CARES Act FDA on Signing of the COVID-19 Emergency Relief Bill, Including Landmark Over-the-Counter …
Building Quality into the Design and Conduct of Clinical Studies: Integrating Quality by Design (QbD) and Risk-Based Monitoring (RBM) Approaches - 01/31/2024
… have not been fully utilized. Additionally, as the COVID-19 pandemic necessitated changes to clinical trial design and …
FDA-M CERSI: Analgesic Clinical Trial Designs, Extrapolation, and Endpoints in Patients from Birth to Less Than Two Years of Age Public Workshop - 10/13/2021 - 10/14/2021
… format only . Please note that due to the impact of this COVID-19 pandemic, all meeting participants will be joining this …
Webinar: Monograph reform is here! Learn what to expect and how to prepare. - 05/29/2020
… RESOURCES Status of OTC Rulemakings FDA on Signing of the COVID-19 Emergency Relief Bill, Including Landmark Over-the-Counter …
UPDATED INFORMATION: October 17 – 19, 2022: Hearing Announcement involving the Obstetrics, Reproductive, and Urologic Drugs Advisory Committee - 10/17/2022
… during the hearing. UPDATED INFORMATION (as of October 19, 2022): The start time for October 19, 2022 (Day 3) has changed to 8:30 a.m. Eastern Time. All … Location: Please note that due to the impact of this COVID-19 pandemic, all meeting participants will be joining …