Policy for Certain REMS Requirements During the Tocilizumab Shortage Related to the COVID-19 Public Health Emergency |
Guidance for Industry and Health Care Professionals |
Biologics
Gene Therapy |
December 10, 2021 |
Development of Abbreviated New Drug Applications During the COVID-19 Pandemic – Questions and Answers Guidance for Industry |
Final Guidance for Industry |
Drugs |
September 8, 2021 |
Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers (Updated May 17, 2021) |
Final Guidance for Industry |
Biologics
Drugs |
May 17, 2021 |
COVID-19: Master Protocols Evaluating Drugs and Biological Products for Treatment or Prevention |
Final Guidance for Industry |
Biologics
Drugs |
May 17, 2021 |
Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency Guidance for Industry |
Final Guidance for Industry |
Biologics
Drugs
Animal & Veterinary |
April 14, 2021 |
COVID-19 Container Closure System and Component Changes: Glass Vials and Stoppers Guidance for Industry |
Final Guidance for Industry |
Biologics
Drugs |
March 4, 2021 |
Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests |
Final Guidance for Test Developers and Food and Drug Administration Staff |
Medical Devices |
February 22, 2021 |
Development of Monoclonal Antibody Products Targeting SARS-CoV-2, Including Addressing the Impact of Emerging Variants, During the COVID 19 Public Health Emergency |
Final Guidance for Industry |
Drugs |
February 22, 2021 |
Manufacturing Considerations for Licensed and Investigational Cellular and Gene Therapy Products During COVID-19 Public Health Emergency |
Final Guidance for Industry |
Biologics |
January 19, 2021 |
Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol, Including During the Public Health Emergency (COVID-19) |
Final Guidance for Industry |
Drugs |
January 19, 2021 |
Protecting Participants in Bioequivalence Studies for Abbreviated New Drug Applications During the COVID-19 Public Health Emergency |
Final Guidance for Industry |
Drugs |
January 15, 2021 |
Coagulation Systems for Measurement of Viscoelastic Properties: Enforcement Policy During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised) |
Final Guidance for Industry |
Medical Devices |
January 28, 2021 |
COVID-19: Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting SARS-CoV-2 Infectivity |
Final Guidance for Industry |
Drugs |
January 13, 2021 |
Review Timelines for Applicant Responses to Complete Response Letters When a Facility Assessment Is Needed During the COVID-19 Public Health Emergency |
Final Guidance for Industry |
Biologics
Drugs |
December 21, 2020 |
Enforcement Policy for the Quality Standards of the Mammography Quality Standards Act During the COVID-19 Public Health Emergency |
Final Guidance for Mammography Facilities, State MQSA Contract Partners, FDA-Approved MQSA Accreditation Bodies, and Food and Drug Administration Staff |
Medical Devices
Radiation-Emitting Products
Radiology
Radiological Health |
December 4, 2020 |
Enforcement Policy for Modifications to FDA Cleared Molecular Influenza and RSV Tests During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency |
Final Guidance for Industry and FDA Staff |
Medical Devices |
October 13, 2020 |
Emergency Use Authorization for Vaccines to Prevent COVID-19 (Updated) |
Final Guidance for Industry |
Biologics |
May 25, 2021 |
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 |
Final Guidance for Industry |
Biologics
Drugs |
September 14, 2020 |
Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency |
Final Guidance for Industry |
Biologics
Drugs
Animal & Veterinary |
September 10, 2020 |
Enforcement Policy for Viral Transport Media During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised) |
Final Guidance for Commercial Manufacturers, Clinical Laboratories, and FDA Staff |
Medical Devices |
November 15, 2021 |
FDA Guidance on Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency (Updated August 30, 2021) |
Final Guidance for Industry, Investigators, and Institutional Review Boards |
Drugs
Biologics
Medical Devices
|
August 30, 2021 |
Development and Licensure of Vaccines to Prevent COVID-19 |
Final Guidance for Industry |
Biologics |
June 30, 2020 |
Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices - Questions and Answers |
Final Guidance for Industry and FDA Staff |
Biologics
Medical Devices |
December 22, 2020 |
Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing |
Final Guidance for Industry |
Animal & Veterinary
Biologics
Drugs
|
June 19, 2020 |
Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency Guidance for Industry |
Final Guidance for Industry |
Animal & Veterinary
Biologics
Drugs
Medical Devices |
June 16, 2020 |
Temporary Policy on Prescription Drug Marketing Act Requirements for Distribution of Drug Samples During the COVID-19 Public Health Emergency |
Final Guidance for Industry |
Drugs |
June 8, 2020 |
Institutional Review Board (IRB) Review of Individual Patient Expanded Access Requests for Investigational Drugs and Biological Products During the COVID-19 Public Health Emergency |
Final Guidance for IRBs and Clinical Investigators |
Drugs
Biologics |
June 2, 2020 |
Reporting a Temporary Closure or Significantly Reduced Production by a Human Food Establishment and Requesting FDA Assistance During the COVID-19 Public Health Emergency |
Final Guidance for Industry |
Food & Beverages |
May 27, 2020 |
Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications — Questions and Answers |
Final Guidance for Industry |
Biologics
Drugs
|
May 26, 2020 |
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 |
Final Guidance for Industry |
Food & Beverages |
May 22, 2020 |
Temporary Policy Regarding Certain Food Labeling Requirements During the COVID-19 Public Health Emergency: Minor Formulation Changes and Vending Machines |
Final Guidance for Industry |
Food & Beverages |
May 22, 2020 |
Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency |
Final Guidance for Industry and FDA Staff |
Biologics
Medical Devices
|
May 21, 2020 |
Returning Refrigerated Transport Vehicles and Refrigerated Storage Units to Food Uses After Using Them to Preserve Human Remains During the COVID-19 Pandemic |
Final Guidance for Industry |
Animal & Veterinary
Food & Beverages
|
May 12, 2020 |
COVID-19 Public Health Emergency: General Considerations for Pre-IND Meeting Requests for COVID-19 Related Drugs and Biological Products |
Final Guidance for Industry and Investigators |
Drugs
Biologics
|
May 11, 2020 |
COVID-19: Developing Drugs and Biological Products for Treatment or Prevention (Updated) |
Final Guidance for Industry |
Drugs
Biologics
|
February 22, 2021 |
Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised) |
Final Guidance for Developers and Food and Drug Administration Staff |
Medical Devices |
November 15, 2021 |
Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Outsourcing Facilities During the COVID-19 Public Health Emergency (Revised) |
Final Guidance for Industry |
Drugs |
May 21, 2020 |
Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Pharmacy Compounders not Registered as Outsourcing Facilities During the COVID-19 Public Health Emergency (Revised) |
Final Guidance for Industry |
Drugs |
May 21, 2020 |
Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic |
Final Guidance for Industry |
Food & Beverages
Drugs
Biologics
Medical Devices
|
May 8, 2020 |
CVM GFI #271 Reporting and Mitigating Animal Drug Shortages during the COVID-19 Public Health Emergency |
Final Guidance for Industry |
Animal & Veterinary |
May 7, 2020 |
Notifying CDRH of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act During the COVID-19 Public Health Emergency |
Final Guidance for Industry and FDA Staff |
Medical Devices |
November 25, 2020 |
Investigational COVID-19 Convalescent Plasma |
Final Guidance for Industry |
Biologics |
February 11, 2021 |
Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act During the COVID-19 Public Health Emergency |
Final Guidance for Industry |
Drugs
Biologics
|
April 30, 2020 |
Enforcement Policy for Remote Digital Pathology Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency |
Final Guidance for Industry, Clinical Laboratories, Heathcare Facilities, Pathologists, and FDA Staff |
Medical Devices |
April 24, 2020 |
Enforcement Policy for Imaging Systems During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency |
Final Guidance for Industry and FDA Staff |
Medical Devices |
April 23, 2020 |
Enforcement Policy for Non-Invasive Fetal and Maternal Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency |
Final Guidance for Industry and FDA Staff |
Medical Devices |
April 23, 2020 |
Temporary Policy Regarding Accredited Third-Party Certification Program Onsite Observation and Certificate Duration Requirements During the COVID-19 Public Health Emergency |
Final Guidance for Industry |
Food & Beverages |
April 22, 2020 |
Temporary Policy on Repackaging or Combining Propofol Drug Products During the COVID-19 Public Health Emergency |
Final Guidance for Industry |
Drugs |
April 22, 2020 |
Enforcement Policy for Telethermographic Systems During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency |
Final Guidance for Industry and FDA Staff |
Medical Devices |
April 16, 2020 |
Enforcement Policy for Digital Health Devices For Treating Psychiatric Disorders During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency |
Final Guidance for Industry and FDA Staff |
Medical Devices |
April 14, 2020 |
Product-Specific Guidances for Chloroquine Phosphate and Hydroxychloroquine Sulfate |
Final Product-Specific Guidances for Generic Drug Development |
Drugs |
April 13, 2020 |
Temporary Policy Regarding Non-Standard PPE Practices for Sterile Compounding by Pharmacy Compounders not Registered as Outsourcing Facilities During the COVID-19 Public Health Emergency |
Final Guidance for Industry |
Drugs |
May 14, 2020 |
Policy for the Temporary Use of Portable Cryogenic Containers Not in Compliance With 21 CFR 211.94(e)(1) For Oxygen and Nitrogen During the COVID-19 Public Health Emergency |
Final Guidance for Industry |
Drugs |
April 20, 2020 |
Enforcement Policy for Extracorporeal Membrane Oxygenation and Cardiopulmonary Bypass Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency |
Final Guidance for Industry and FDA Staff |
Medical Devices |
April 6, 2020 |
Enforcement Policy for Remote Ophthalmic Assessment and Monitoring Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency |
Final Guidance for Industry and FDA Staff |
Medical Devices |
April 6, 2020 |
Temporary Policy Regarding Enforcement of 21 CFR Part 118 (the Egg Safety Rule) During the COVID-19 Public Health Emergency |
Final Guidance for Egg Producers |
Food & Beverages |
April 6, 2020 |
Enforcement Policy for Infusion Pumps and Accessories During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency |
Final Guidance for Industry and FDA Staff |
Medical Devices |
April 5, 2020 |
Enforcement Policy for Clinical Electronic Thermometers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency |
Final Guidance for Industry and FDA Staff |
Medical Devices |
April 4, 2020 |
CVM GFI #270 - Guidance on the Conduct and Review of Studies to Support New Animal Drug Development during the COVID-19 Public Health Emergency |
Final Guidance for Industry |
Animal & Veterinary |
April 3, 2020 |
Temporary Policy Regarding Packaging and Labeling of Shell Eggs Sold by Retail Food Establishments During the COVID-19 Public Health Emergency |
Final Guidance for Industry |
Food & Beverages |
April 3, 2020 |
Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised) |
Final Guidance for Industry and FDA Staff |
Medical Devices |
September 15, 2021 |
Alternative Procedures for Blood and Blood Components During the COVID-19 Public Health Emergency |
Final Guidance for Industry |
Biologics |
April 2, 2020 |
Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products |
Final Guidance for Industry |
Biologics |
August 27, 2020 |
Revised Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria |
Final Guidance for Industry |
Biologics |
April 2, 2020 |
Temporary Policy Regarding Nutrition Labeling of Standard Menu Items in Chain Restaurants and Similar Retail Food Establishments During the COVID-19 Public Health Emergency |
Final Guidance for Industry |
Food & Beverages |
April 1, 2020 |
Enforcement Policy for Gowns, Other Apparel, and Gloves During the Coronavirus Disease (COVID-19) Public Health Emergency |
Final Guidance for Industry and FDA Staff |
Medical Devices |
March 30, 2020 |
Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency |
Final Guidance for Industry and FDA Staff |
Medical Devices |
March 29, 2020 |
Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act Guidance for Industry |
Final Guidance for Industry |
Drugs
Biologics
|
March 27, 2020 |
Temporary Policy Regarding Nutrition Labeling of Certain Packaged Food During the COVID-19 Public Health Emergency |
Final Guidance for Industry |
Food & Beverages |
March 26, 2020 |
CVM GFI #269 - Enforcement Policy Regarding Federal VCPR Requirements to Facilitate Veterinary Telemedicine During the COVID-19 Outbreak |
Final Guidance for Industry |
Animal & Veterinary |
March 24, 2020 |
Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) (Revised) |
Final Guidance for Industry |
Drugs |
February 11, 2021 |
Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency |
Final Guidance for Industry and FDA Staff |
Medical Devices |
March 22, 2020 |
Policy for Certain REMS Requirements During the COVID-19 Public Health Emergency Guidance for Industry and Health Care Professionals |
Final Guidance for Industry and Health Care Professionals |
Drugs
Biologics
|
March 22, 2020 |
Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease-2019 (COVID-19) Public Health Emergency (Revised) |
Final Guidance for Industry and FDA Staff |
Medical Devices |
October 28, 2020 |
Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) (Revised) |
Final Guidance for Industry |
Drugs |
February 10, 2021 |
Temporary Policy Regarding Preventive Controls and FSVP Food Supplier Verification Onsite Audit Requirements During the COVID-19 Public Health Emergency |
Final Guidance for Industry |
Food & Beverages
Animal & Veterinary
|
June 4, 2020 |
Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (Revised) |
Immediately in Effect Guidance for Industry |
Drugs |
February 10, 2021 |