While clinical trials are ongoing to determine the safety and effectiveness of hydroxychloroquine and chloroquine for #COVID19, there are known side effects of these medications that should be considered. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-reiterates-importance-close-patient-supervision-label-use   … pic.twitter.com/4KnWycQKDE
While clinical trials are ongoing to determine the safety and effectiveness of hydroxychloroquine and chloroquine for #COVID19, there are known side effects of these medications that should be considered. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-reiterates-importance-close-patient-supervision-label-use … pic.twitter.com/4KnWycQKDE (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 24, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

New FDA Drug Safety Communication on hydroxychloroquine and chloroquine: https://go.usa.gov/xvQGM   pic.twitter.com/XU6FF39Eyu
New FDA Drug Safety Communication on hydroxychloroquine and chloroquine: https://go.usa.gov/xvQGM  pic.twitter.com/XU6FF39Eyu (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 24, 2020 Category: Medical Devices Authors: ( at FDA_Drug_Info) Source Type: news

Learn how FDA ’ s Sentinel System is being used during the #COVID19 pandemic to monitor the use of drugs, describe the course of illness among hospitalized patients, & evaluate treatment impact of therapies actively being used under real-world conditions: http://ow.ly/4o1d50zmRIG   pic.twitter.com/a8ABBLkEEO
Learn how FDA’s Sentinel System is being used during the #COVID19 pandemic to monitor the use of drugs, describe the course of illness among hospitalized patients, & evaluate treatment impact of therapies actively being used under real-world conditions: http://ow.ly/4o1d50zmRIG  pic.twitter.com/a8ABBLkEEO (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 23, 2020 Category: Medical Devices Authors: ( at FDA_Drug_Info) Source Type: news

FDA remains laser-focused in our fight against #COVID19. Here is the latest update on our actions: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-april-22-2020   … pic.twitter.com/cyf1E76gNG
FDA remains laser-focused in our fight against #COVID19. Here is the latest update on our actions: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-april-22-2020 … pic.twitter.com/cyf1E76gNG (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 22, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

The FDA celebrates the life of former FDA Commissioner Donald Kennedy, Ph.D., who passed away Tuesday at the age of 88. He served as Commissioner from April 1977 – June 1979. We extend our deepest sympathies to his family, friends and colleagues. https://www.fda.gov/about-fda/fda-leadership-1907-today/donald-kennedy   … pic.twitter.com/uKjk0lP3fa
The FDA celebrates the life of former FDA Commissioner Donald Kennedy, Ph.D., who passed away Tuesday at the age of 88. He served as Commissioner from April 1977 – June 1979. We extend our deepest sympathies to his family, friends and colleagues. https://www.fda.gov/about-fda/fda-leadership-1907-today/donald-kennedy … pic.twitter.com/uKjk0lP3fa (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 22, 2020 Category: Medical Devices Authors: ( at US_FDA) Source Type: news

Reminder. https://twitter.com/FDADeviceInfo/status/1252644085736890369   …
Reminder. https://twitter.com/FDADeviceInfo/status/1252644085736890369 … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 22, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

To help meet consumer demand and support the food supply chain during the #COVID19 pandemic, @US_FDA is providing increased flexibility to the food industry. @DrMayneFDAFood shares FDA ’ s efforts in our latest #FDAVoices Blog: https://www.fda.gov/news-events/fda-voices-perspectives-fda-leadership-and-experts/fda-provides-flexibility-food-industry-support-food-supply-chain-and-meet-consumer-demand-during   …
To help meet consumer demand and support the food supply chain during the #COVID19 pandemic, @US_FDA is providing increased flexibility to the food industry. @DrMayneFDAFood shares FDA’s efforts in our latest #FDAVoices Blog: https://www.fda.gov/news-events/fda-voices-perspectives-fda-leadership-and-experts/fda-provides-flexibility-food-industry-support-food-supply-chain-and-meet-consumer-demand-during … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 22, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

As we move rapidly to combat this pandemic, FDA has issued 42 individual emergency use authorizations for #COVID19 test kit manufacturers and laboratories. Most recently, an EUA was issued to Trax Management Services Inc. ’ s PhoenixDx 2019-CoV. https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#covid19ivd   …
As we move rapidly to combat this pandemic, FDA has issued 42 individual emergency use authorizations for #COVID19 test kit manufacturers and laboratories. Most recently, an EUA was issued to Trax Management Services Inc.’s PhoenixDx 2019-CoV. https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#covid19ivd … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 22, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

We ’ re proud to play a role in the whole-of-government effort to fight #COVID19. Here is the latest update on FDA ’ s activities: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-april-21-2020   … pic.twitter.com/YPb22v9ZVD
We’re proud to play a role in the whole-of-government effort to fight #COVID19. Here is the latest update on FDA’s activities: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-april-21-2020 … pic.twitter.com/YPb22v9ZVD (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 22, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

REMINDER: Flagging for developers of tests for SARS-CoV-2: Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests. Wednesday April 22, 2020 12:15-1:15 ET. http://go.usa.gov/xv3hx   pic.twitter.com/sgeJNDneeT
REMINDER: Flagging for developers of tests for SARS-CoV-2: Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests. Wednesday April 22, 2020 12:15-1:15 ET. http://go.usa.gov/xv3hx  pic.twitter.com/sgeJNDneeT (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 21, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

The guidance explains how an owner, operator, or agent in charge of a device establishment may submit a request for nonbinding feedback to the FDA about self proposed corrective actions. Find out more about this #MedicalDevice guidance. https://go.usa.gov/xvNAK  
The guidance explains how an owner, operator, or agent in charge of a device establishment may submit a request for nonbinding feedback to the FDA about self proposed corrective actions. Find out more about this #MedicalDevice guidance. https://go.usa.gov/xvNAK  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 21, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Today, @US_FDA issued the final guidance, “ Nonbinding Feedback After Certain FDA Inspections of Device Establishments ” .pic.twitter.com/ao1N2Lq5e2
Today, @US_FDA issued the final guidance, “Nonbinding Feedback After Certain FDA Inspections of Device Establishments”. pic.twitter.com/ao1N2Lq5e2 (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 21, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Today, FDA took the following actions in our ongoing effort to combat the #COVID19 pandemic: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-april-20-2020   … pic.twitter.com/gUXiVtYyvE
Today, FDA took the following actions in our ongoing effort to combat the #COVID19 pandemic: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-april-20-2020 … pic.twitter.com/gUXiVtYyvE (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 21, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

If you ’ ve fully recovered from #COVID19, you may be able to donate plasma to help others. You must have complete resolution of symptoms for at least 28 days OR have no symptoms for at least 14 days prior to donation & a negative COVID-19 lab test. https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/donate-covid-19-plasma   … pic.twitter.com/uDuyFU6g1C
If you’ve fully recovered from #COVID19, you may be able to donate plasma to help others. You must have complete resolution of symptoms for at least 28 days OR have no symptoms for at least 14 days prior to donation & a negative COVID-19 lab test. https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/donate-covid-19-plasma … pic.twitter.com/uDuyFU6g1C (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 19, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news

Serological tests can help identify whether or not a person has developed antibodies to #COVID19. FDA is working to ensure accurate & reliable tests are widely available, while protecting Americans from tests with false or unsubstantiated claims. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-serological-test-validation-and-education-efforts   … pic.twitter.com/nw2SwamFM9
Serological tests can help identify whether or not a person has developed antibodies to #COVID19. FDA is working to ensure accurate & reliable tests are widely available, while protecting Americans from tests with false or unsubstantiated claims. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-serological-test-validation-and-education-efforts … pic.twitter.com/nw2SwamFM9 (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 19, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news