Investigational COVID-19 Convalescent Plasma – Emergency INDs

FDA is facilitating access to COVID-19 convalescent plasma for use in patients with serious or immediately life-threatening COVID-19 infections through the process of single patient emergency Investigational New Drug Applications (eINDs) for Individual patients under 21 CFR 312.310. This process allows the use of an investigational drug for the treatment of an individual patient by a licensed physician upon FDA authorization. This does not include the use of COVID-19 convalescent plasma for the prevention of infection.

Click here to access the complete information.

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/dr-reddys-laboratories-issues-voluntary-nationwide-recall-phytonadione-injectable-emulsion-usp-10

http://www.fda.gov/safety/medical-product-safety-information/fecal-microbiota-transplantation-safety-alert-regarding-additional-safety-protections-pertaining

The U.S. Food and Drug Administration is actively and aggressively monitoring the market for any firms marketing products with fraudulent coronavirus (COVID-19) diagnostic, prevention and treatment claims as part of our ongoing efforts to protect public health during this pandemic. As a result of these activities, the agency is beginning to see unauthorized fraudulent test kits that are being marketed to test for COVID-19 in the home.

For more information go to

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-alerts-consumers-about-unauthorized-fraudulent-covid-19-test-kits

On diagnostics for COVID-19

• FDA has issued an Immediately In Effect Guidance for laboratories and commercial manufacturers to help accelerate the use of test they develop in order to achieve more rapid and widespread testing capacity.  The guidance also provides FDA’s recommendations regarding validation of COVID-19 tests (see section V of the guidance).  The guidance can be found at the following link:

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-provides-more-regulatory-relief-during-outbreak-continues-help

• FDA maintains a listing of the tests that are authorized for COVID-19 testing on this webpage: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#coronavirus2019.   There are currently 9 FDA-authorized tests for COVID-19. Under the description of each test there are links to the FDA authorization letter, a package insert which describes the studies used to verify/validate the test and fact sheets for patients and physicians. 

Other actions

• FDA issued a guidance on conducting clinical trials during the pandemic to help industry and investigators navigate the COVID-19 pandemic and move forward with conducting clinical trials.

• FDA has issued a letter to healthcare providers with recommendations for conservation strategies of personal protective equipment (e.g. gowns and surgical masks) for use by healthcare organizations and personnel.  This letter can be found at the following link:  https://www.fda.gov/medical-devices/letters-health-care-providers/surgical-mask-and-gown-conservation-strategies-letter-healthcare-providers.  Also see: FAQs on Shortages of Surgical Masks and Gowns.

• FDA also announced that they would be taking steps to make more respirators, including certain N95s, available to health care personnel. Currently, the majority of respirators on the market are indicated for use in industrial settings. This action allows certain National Institute for Occupational Safety and Health (NIOSH) approved respirators not currently regulated by the FDA to be used in a health care setting by health care personnel during the coronavirus (COVID-19) outbreak, thereby maximizing the number of respirators available to meet the needs of the U.S. health care system.  https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-and-cdc-take-action-increase-access-respirators-including-n95s

FDA maintains a webpage dedicated to announcements and information related to COVID, which is updated daily.  It can be found at the following link:  https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/coronavirus-disease-2019-covid-19

Announcement about Ibuprofen and COVID-19 (Washington, DC. 18 March, 2020)

European Medicine Agency (EMA) is aware of reports, especially on social media, which raise questions about whether non-steroidal anti-inflammatory medicines (NSAIDs) such as ibuprofen could worsen coronavirus disease (COVID-19).

There is currently no scientific evidence establishing a link between ibuprofen and worsening of COVID‑19. EMA is monitoring the situation closely and will review any new information that becomes available on this issue in the context of the pandemic.

For more information go to https://www.ema.europa.eu/en/news/ema-gives-advice-use-non-steroidal-anti-inflammatories-covid-19