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 …

Recommendations for Investigational and Licensed COVID-19 Convalescent Plasma

… Biologics License Application (BLA) for the manufacture of COVID-19 convalescent plasma for transfusion intended to treat … New Drug applications (INDs) for investigational COVID-19 convalescent plasma for transfusion. FDA is …

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

… vaccines for the prevention of Coronavirus Disease 2019 (COVID-19) which is caused by severe acute respiratory syndrome … to providing timely guidance to support the response to COVID-19.  The recommendations described in the guidance are …

Policy for Evaluating Impact of Viral Mutations on COVID-19 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 …

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 …

Investigational COVID-19 Convalescent Plasma

… diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic.  FDA is committed to providing timely guidance … 2020, FDA issued an Emergency Use Authorization (EUA)  for COVID-19 convalescent plasma for the treatment of …

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

… are subject to modified rule requirements. During the COVID-19 public health emergency as declared by the Secretary of … communicates FDA’s current thinking on how, when the COVID-19 public health emergency expires, qualified exempt …

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

… and Barrier Face Coverings During the Coronavirus Disease (COVID-19) Public Health Emergency" (latest version published March … and Barrier Face Coverings for the Coronavirus Disease (COVID-19) Response." This guidance was originally part of the …

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 …

Withdrawn Guidances (Biologics)

… Emergency Use Authorization for Vaccines to Prevent COVID-19 - Final 2022-03-31 2024-09-06 Donor Screening … During the Tocilizumab Shortage Related to the COVID-19 Public Health Emergency - Final 2022-01-21 …

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 …