Food and Drug Adminstration (FDA): CDRHNew This is an RSS file. You can use it to subscribe to this data in your favourite RSS reader or to display this data on your own website or blog.
Last month, FDA issued a policy providing regulatory flexibility in certain circumstances for validated serological tests performed in laboratories and patient care settings. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-provides-more-regulatory-relief-during-outbreak-continues-help …
Last month, FDA issued a policy providing regulatory flexibility in certain circumstances for validated serological tests performed in laboratories and patient care settings. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-provides-more-regulatory-relief-during-outbreak-continues-help … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 18, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news
Some serological test developers have falsely claimed their tests are FDA authorized or that their tests can diagnose #COVID19. When we become aware of this, we take appropriate action against firms making or distributing unvalidated tests or making false claims.
(Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 18, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news
As #COVID19 mitigation efforts continue to #FlattenTheCurve, many Americans are wondering when they can resume normal activities. Antibody tests — or serological tests — could play a role in this complex calculation. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-serological-test-validation-and-education-efforts … pic.twitter.com/qHao5l2Tzs
As #COVID19 mitigation efforts continue to #FlattenTheCurve, many Americans are wondering when they can resume normal activities. Antibody tests—or serological tests—could play a role in this complex calculation. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-serological-test-validation-and-education-efforts … pic.twitter.com/qHao5l2Tzs (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 18, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news
To continue to expand #COVID19 testing capability, @US_FDA has updated information on its website regarding swabs used to collect patient samples for #COVID19 testing to include spun synthetic nasal swabs. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-gates-foundation-unitedhealth-group-quantigen-and-us-cotton … pic.twitter.com/oNoJGcOopB
To continue to expand #COVID19 testing capability, @US_FDA has updated information on its website regarding swabs used to collect patient samples for #COVID19 testing to include spun synthetic nasal swabs. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-gates-foundation-unitedhealth-group-quantigen-and-us-cotton … pic.twitter.com/oNoJGcOopB (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 18, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news
FDA encourages health care professionals and consumers to report adverse events or quality problems experienced with the use of #COVID19 products to the FDA ’ s MedWatch Adverse Event Reporting program. https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program …
FDA encourages health care professionals and consumers to report adverse events or quality problems experienced with the use of #COVID19 products to the FDA’s MedWatch Adverse Event Reporting program. https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 17, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news
Today, a federal court entered a temporary injunction against the Genesis II Church of Health and Healing requiring them to immediately stop distributing “ Miracle Mineral Solution, ” an unproven, potentially harmful product that claims to treat #COVID19 https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-federal-judge-enters-temporary-injunction-against-genesis-ii-church … pic.twitter.com/8Z5qeaeiZQ
Today, a federal court entered a temporary injunction against the Genesis II Church of Health and Healing requiring them to immediately stop distributing “Miracle Mineral Solution,” an unproven, potentially harmful product that claims to treat #COVID19 https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-federal-judge-enters-temporary-injunction-against-genesis-ii-church … pic.twitter.com/8Z5qeaeiZQ (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 17, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news
Collaboration through the ACTIV partnership is critical for success & FDA will continue to use every tool possible under our #Coronavirus Treatment Acceleration Program to speed the development of safe & effective medical countermeasures. https://twitter.com/NIH/status/1251134603894484997 …
Collaboration through the ACTIV partnership is critical for success & FDA will continue to use every tool possible under our #Coronavirus Treatment Acceleration Program to speed the development of safe & effective medical countermeasures. https://twitter.com/NIH/status/1251134603894484997 … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 17, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news
As we continue to increase the number of authorized #COVID19 tests, we ’ ve worked with 315+ test developers who have said they will submit EUA requests for diagnostic tests. 190+ labs have begun testing under our Policy for Diagnostic Tests for Coronavirus Disease-2019.
As we continue to increase the number of authorized #COVID19 tests, we’ve worked with 315+ test developers who have said they will submit EUA requests for diagnostic tests. 190+ labs have begun testing under our Policy for Diagnostic Tests for Coronavirus Disease-2019. (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 17, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news
To date, we ’ ve issued 37 emergency use authorizations (EUAs) for #COVID19 diagnostic tests. Most recently, EUAs were issued to Mount Sinai Laboratory ’ s COVID-19 ELISA IgG Antibody Test & Maccura Biotechnology (USA) LLC ’ s SARS-CoV-2 Fluorescent PCR Kit. https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#covid19ivd …
To date, we’ve issued 37 emergency use authorizations (EUAs) for #COVID19 diagnostic tests. Most recently, EUAs were issued to Mount Sinai Laboratory’s COVID-19 ELISA IgG Antibody Test & Maccura Biotechnology (USA) LLC’s SARS-CoV-2 Fluorescent PCR Kit. 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 17, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news
We issued guidance help expand the availability of telethermographic systems used for body temperature measurements for triage use during the #COVID19 public health emergency. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-telethermographic-systems-during-coronavirus-disease-2019-covid-19-public-health …
We issued guidance help expand the availability of telethermographic systems used for body temperature measurements for triage use during the #COVID19 public health emergency. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-telethermographic-systems-during-coronavirus-disease-2019-covid-19-public-health … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 17, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news
We updated the question-and-answer appendix in a guidance on conducting clinical trials of medical products during the #COVID19 pandemic. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-pandemic …
We updated the question-and-answer appendix in a guidance on conducting clinical trials of medical products during the #COVID19 pandemic. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-pandemic … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 17, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news
FDA issued a temporary policy for outsourcing facilities to compound certain drugs for hospitalized patients during the #COVID19 pandemic when hospitals aren ’ t able to access FDA-approved drugs. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/temporary-policy-compounding-certain-drugs-hospitalized-patients-outsourcing-facilities-during-covid …
FDA issued a temporary policy for outsourcing facilities to compound certain drugs for hospitalized patients during the #COVID19 pandemic when hospitals aren’t able to access FDA-approved drugs. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/temporary-policy-compounding-certain-drugs-hospitalized-patients-outsourcing-facilities-during-covid … (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 17, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news
Our top priority during the #COVID19 pandemic is protecting the public health and safety. Here is an update on FDA ’ s latest actions: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-april-16-2020 … pic.twitter.com/ezNbJzQL1Z
Our top priority during the #COVID19 pandemic is protecting the public health and safety. Here is an update on FDA’s latest actions: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-april-16-2020 … pic.twitter.com/ezNbJzQL1Z (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 17, 2020 Category: Medical Devices Authors: ( at SteveFDA) Source Type: news
FDA has heard your concerns about shopping for #food safely. We want to assure you there is currently NO evidence of human or animal food or food packaging being associated with transmission of the #COVID19 . More food shopping info here: https://go.usa.gov/xv86k
FDA has heard your concerns about shopping for #food safely. We want to assure you there is currently NO evidence of human or animal food or food packaging being associated with transmission of the #COVID19 . More food shopping info here: https://go.usa.gov/xv86k (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 16, 2020 Category: Medical Devices Authors: ( at FDAfood) Source Type: news
FDA is facilitating development of & access to convalescent plasma as potential #COVID19 treatment. If you ’ ve recovered from COVID-19 for at least 28 days OR have no symptoms for at least 14 days & a negative COVID-19 lab test, consider donating plasma https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-encourages-recovered-patients-donate-plasma-development-blood … pic.twitter.com/jEwXv1COpC
FDA is facilitating development of & access to convalescent plasma as potential #COVID19 treatment. If you’ve recovered from COVID-19 for at least 28 days OR have no symptoms for at least 14 days & a negative COVID-19 lab test, consider donating plasma https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-encourages-recovered-patients-donate-plasma-development-blood … pic.twitter.com/jEwXv1COpC (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - April 16, 2020 Category: Medical Devices Authors: ( at US_FDA) Source Type: news