FDA COVID-19 Initiatives

COVID-19 UPDATES

The FDA is engaged in numerous activities to protect and promote public health during the coronavirus disease 2019 (COVID-19) pandemic. For CDER, these efforts include accelerating development of treatments for COVID-19, maintaining and securing drug supply chains, providing guidance to stakeholders, advising developers on how to handle clinical trial issues, and keeping the public informed. Information on some of FDA’s efforts related directly to drugs and COVID-19 can be found in the links below:  Coronavirus (COVID-19) Drugs Web Page https://www.fda.gov/drugs/emergency-preparedness-drugs/coronavirus-covid-19-drugs FDA Coronavirus Treatment Acceleration Program (CTAP) https://www.fda.gov/drugs/coronavirus-covid-19-drugs/coronavirus-treatment-acceleration-program-ctap

FDA COVID-19 Initiatives 

FDA COVID-19 Response At-A-Glance Summary as of August 14, 2020 https://www.fda.gov/media/137005/download  Innovation to respond to COVID-19 https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/innovation-respond-covid-19

FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency  Issued on 18 March 2020 and updated  most recently on 2 July 2020, this guidance emphasizes safety of trial participants as the paramount consideration during the pandemic. It also includes recommendations on protecting trial integrity and helping to maintain compliance with Good Clinical Practice and  an appendix of questions and answers that is expanded with each update of the Guidance based on issues raised by stakeholders.  Information on Conduct of Clinical Trials during the COVID 19 Pandemic New FDA mailbox was established at Clinicaltrialconduct-COVID19@fda.hhs.gov dedicated to COVID-19-related inquiries. As of 7 Aug 2020, 485 inquiries have been received and responses have been provided for 481 of these. Inquiries to this mailbox have informed the FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency, can be found here. For information on drug development inquiries for drugs to address COVID 19, click here FDA-CDER COVID-19 Critical Care Drug Monitoring Survey Portal FDA is tasked with helping to ensure that an adequate drug supply is available to meet public health needs, such as in a pandemic response. The Agency has established a voluntary self-reporting platform for hospitals and healthcare systems to provide real-world data (RWD) on their supply of COVID-19-related critical care drugs. FDA utilizes the survey responses, in addition to other available drug supply chain information, in a comprehensive way to support our mission during this public health emergency—by anticipating where demand may be expected to increase for certain drugs, as well as by enabling CDER to explore all possible actions and undertake a timely and responsive action on mitigating potential or actual drug shortages. Information and videos are available describing the registration process and survey completion steps involved.

FDA Updates on hand sanitizers  FDA is warning consumers and health care providers that the agency has seen a sharp increase in hand sanitizer products that are labeled to contain ethanol but that have tested positive for methanol or 1-propanol contamination. FDA test results have also shown that  certain hand sanitizers are subpotent and have concerningly low levels of ethyl alcohol or isopropyl alcohol.  FDA continues to update its do-not-use list of hand sanitizers at www.fda.gov/unsafehandsanitizers.  FDA also continues to update the hand sanitizer guidances, as needed, including clarification on impurity levels and testing ethanol for methanol to help ensure widespread access to alcohol-based hand sanitizers that are free of contamination.  COVID MyStudies Application (App) FDA is making its previously developed FDA MyStudies app available to investigators during the COVID-19 Public Health Emergency as a free platform to securely obtain patients’ informed consent for eligible clinical trials when face-to-face contact is not possible or practical due to COVID-19 control measures. Learn more