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Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment
… of a final guidance for industry entitled “Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent … in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment.” Although the public …
Emergency Use Authorization for Vaccines to Prevent COVID-19
… ance-documents/emergency-use-authorization-vaccines-prevent-covid-19 … Vaccines … This guidance is intended to remain in effect … 5094/guidance-documents-related-to-coronavirus-disease-2019-covid-19 . FDA plays a critical role in protecting the United …
COVID-19: Developing Drugs and Biological Products for Treatment or Prevention
… availability of a final guidance for industry entitled “COVID-19: Developing Drugs and Biological Products for Treatment … and biological products for the treatment or prevention of COVID-19. This guidance describes FDA’s current …
Development and Licensure of Vaccines to Prevent COVID-19
… idance-documents/development-and-licensure-vaccines-prevent-covid-19 … Vaccines … FDA is issuing this guidance to assist … vaccines for the prevention of Coronavirus Disease 2019 (COVID-19) which is caused by severe acute respiratory …
Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests (Revised)
… guidance-documents/policy-evaluating-impact-viral-mutations-covid-19-tests-revised … March 24, 2023 - The FDA has finalized two … Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency and Transition Plan for …
COVID-19: Master Protocols Evaluating Drugs and Biological Products for Treatment or Prevention
… diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance … evaluating drugs for the treatment or prevention of COVID-19. … Center for Drug Evaluation and Research … …
Temporary Policy Regarding Accredited Third-Party Certification Program Onsite Observation and Certificate Duration Requirements Due to COVID-19
… diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance … examinations. Due to the ongoing, international impact of COVID-19, FDA is issuing this guidance to temporarily provide …
COVID-19 Container Closure System and Component Changes: Glass Vials and Stoppers Guidance for Industry
… diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance … for Drug Evaluation and Research … Guidance Document … COVID-19 guidance … FDA-2020-D-1136 … Guidance for Industry … …
Investigational COVID-19 Convalescent Plasma
… y-information/search-fda-guidance-documents/investigational-covid-19-convalescent-plasma … Blood Products … FDA plays a … diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely …
Temporary Policy Regarding Preventive Controls and FSVP Food Supplier Verification Onsite Audit Requirements Due to COVID-19
… related to the impact of the coronavirus outbreak (COVID-19), not to enforce requirements in three foods regulations … Food Supplier Verification Onsite Requirements During the COVID-19 Public Health Emergency”) was initially implemented …
Manufacturing Considerations for Licensed and Investigational Cellular and Gene Therapy Products During COVID-19 Public Health Emergency
… diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance … Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological …
Guidance for Industry: Transition from Temporary Policy During the COVID-19 Public Health Emergency Regarding the Qualified Exemption from the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
… uments/guidance-industry-transition-temporary-policy-during-covid-19-public-health-emergency-regarding … This guidance is … are subject to modified rule requirements. During the COVID-19 public health emergency as declared by the Secretary …
Policy for Coronavirus Disease-2019 Tests (Revised)
… Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency and Transition Plan for Medical … Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19) . The guidances outline the FDA's general …
Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
… diseases, including the Coronavirus Disease 2019 (COVID-19). FDA is committed to providing timely guidance to support response efforts to the COVID-19 pandemic. FDA is issuing this guidance to provide …
Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19)
… diseases, including the Coronavirus Disease 2019 (COVID-19). FDA is committed to providing timely guidance to support response efforts to the COVID-19 pandemic. FDA is issuing this guidance to provide …
Enforcement Policy for Face Masks and Barrier Face Coverings During the Coronavirus Disease (COVID-19) Public Health Emergency
… masks-and-barrier-face-coverings-during-coronavirus-disease-covid-19-public … September 5 Update : The FDA is updating and … and Barrier Face Coverings During the Coronavirus Disease (COVID-19) Public Health Emergency" (latest version published …
Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol
… with methanol. During the Coronavirus Disease 2019 (COVID-19) public health emergency (PHE), FDA became aware of … Methanol, Including During the Public Health Emergency (COVID-19)” published in January 2021. … Center for Drug …
Guidance for Industry: Returning Refrigerated Transport Vehicles and Refrigerated Storage Units to Food Uses After Using Them to Preserve Human Remains
… infectious diseases. During the Coronavirus Disease 2019 (COVID-19) pandemic, FDA was asked whether refrigerated food … the guidance so that it is no longer limited to the COVID-19 pandemic. The recommendations in this guidance are …
Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring
… used for patient monitoring at the conclusion of the COVID-19 public health emergency. FDA believes the policy set forth … may help FDA and other stakeholders transition from COVID-19 operations and processes to normal operations and …
Enforcement Policy for Certain Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions
… required to have an approved HDE at the conclusion of the COVID-19 public health emergency. FDA believes the policy set forth … may help FDA and other stakeholders transition from COVID-19 operations and processes to normal operations and …
Enforcement Policy for Clinical Electronic Thermometers
… clinical electronic thermometers at the conclusion of the COVID-19 public health emergency. FDA believes the policy set forth … may help FDA and other stakeholders transition from COVID-19 operations and processes to normal operations and …
Development of Monoclonal Antibody Products Targeting SARS-CoV-2 for Emergency Use Authorization
… SARS-CoV-2 intended for the prevention or treatment of COVID-19, including addressing the impact of emerging variants. … Addressing the Impact of Emerging Variants, During the COVID-19 Public Health Emergency” issued on February 22, …
Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria
… and blood components during the Coronavirus Disease 2019 (COVID-19) public health emergency, in April 2020 FDA (we) issued … blood shortages that occurred as a result of the COVID-19 public health emergency. Further, the guidance …
Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements
… Procedures for Blood and Blood Components During the COVID-19 Public Health Emergency; Guidance for Industry,” dated …
Withdrawn Guidances (Biologics)
… During the Tocilizumab Shortage Related to the COVID-19 Public Health Emergency - Final 2022-01-21 2023-01-17 …