COVID-19 FDA Resources
 
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In the midst of new and unique challenges, many companies are redoubling their development efforts and retooling their manufacturing in response to the COVID-19 pandemic. The Food & Drug Administration (FDA) has responded by rapidly authorizing diagnostics and products through the Emergency Use Authorization process and by providing guidances that seek to expand the availability of certain in-demand medical products, including personal protective equipment, disinfectants, hand sanitizers, diagnostics and medical devices.

Axinn has developed this COVID-19 FDA Resources page to provide relevant articles and other resources, including a complimentary webinar hosted by the Food and Drug Law Institute focused on FDA’s guidances regarding the development of certain medical products. If you have any questions regarding any of these materials or any other FDA issues, please reach out to Chad A. Landmon at clandmon@axinn.com or Matthew S. Murphy at mmurphy@axinn.com.

Bloomberg Law Article

Axinn partner Chad Landmon and associate Drew Hillier authored the Bloomberg Law article, "Open Source Patent Licenses: Pitfalls and Opportunity." INDG originally published this article in Bloomberg Law on June 5 at www.bloombergindustry.com. Reproduced with permission from Copyright 2020 The Bureau of National Affairs, Inc. (800-372-1033) www.bloombergindustry.com.

Webinar Recording

FDLI Webinar, FDA’s Recent COVID-19 Guidances Facilitating Expanded Access to Certain Medical Products, April 14, 2020

American Bar Association SciTech Brief – Short Video
COVID-19: FDA Emergency Use Authorizations

Select FDA Guidances

Bioequivalence Studies

Bioequivalence Studies for Submission in ANDAs during the COVID-19 Pandemic

Clinical Electronic Thermometers

Enforcement Policy for Clinical Electronic Thermometers During the Coronavirus Disease 201E9 (COVID-19) Public Health Emergency

Compounding of Certain Drugs for Hospitalized Patients

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 Guidance for Industry

Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Outsourcing Facilities During the COVID-19 Public Health Emergency

Developing Drugs and Biological Products

COVID-19: Developing Drugs and Biological Products for Treatment or Prevention

Diagnostic Tests

Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency

Digital Health Devices For Treating Psychiatric Disorders

Enforcement Policy for Digital Health Devices For Treating Psychiatric Disorders During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency

Extracorporeal Membrane Oxygenation and Cardiopulmonary Bypass Devices

Enforcement Policy for Extracorporeal Membrane Oxygenation and Cardiopulmonary Bypass Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency

Face Masks

Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised)

General Considerations for Pre-IND

COVID-19 Public Health Emergency: General Considerations for Pre-IND (Investigational New Drug application) Meeting Requests for COVID-19 Related Drugs and Biological Products

Gowns

Enforcement Policy for Gowns, Other Apparel, and Gloves During the Coronavirus Disease (COVID-19) Public Health Emergency

Hand Sanitizers

Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19)

Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) 

Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency 

Infusion Pumps and Accessories

Enforcement Policy for Infusion Pumps and Accessories During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency

Non-Invasive Fetal and Maternal Monitoring Devices

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

Non-Invasive Remote Monitoring

Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease-2019 (COVID-19) Public Health Emergency 

Prescription Drug Samples

Temporary Policy on Prescription Drug Marketing Act Requirements for Distribution of Drug Samples During the COVID-19 Public Health Emergency

Remote Digital Pathology Devices

Enforcement Policy for Remote Digital Pathology Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency

Remote Ophthalmic Assessment and Monitoring Devices

Enforcement Policy for Remote Ophthalmic Assessment and Monitoring Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency

Sponsors Requesting EUAs

Recommendations for Sponsors Requesting EUAs for Decontamination and Bioburden Reduction Systems for Face Masks and Respirators During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency

Ventilators

Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency

Select COVID-19 Resources

Centers for Disease Control and Prevention (CDC)

U.S. Food & Drug Administration (FDA)