FDA Authorizes First Diagnostic Test for Screening of People Without Known or Suspected COVID-19 Infection
July 27, 2020
Silver Spring, MD – The U.S. Food and Drug Administration (FDA) reissued the LabCorp COVID-19 RT-PCR Test emergency use authorization (EUA) to include two new indications for use: testing for people who do not have COVID-19 Coronavirus symptoms or who have no reason to suspect COVID-19 Coronavirus infection, and to allow pooled sample testing.
Coronavirus
FDA Requiring Labeling Changes for Opioid Pain Medicines, Opioid Use Disorder Medicines Regarding Naloxone
July 26, 2020
Silver Spring, MD – The U.S. Food and Drug Administration has announced it is requiring that labeling for opioid pain medicine and medicine to treat opioid use disorder (OUD) be updated to recommend that as a routine part of prescribing these medicines, health care professionals should discuss the availability of naloxone with patients and caregivers, both when beginning and renewing treatment.
Goal is to Help Reduce Opioid Overdoses and Deaths
FDA Coronavirus (COVID-19) Update: July 25th, 2020
July 25, 2020
Silver Spring, MD – The U.S. Food and Drug Administration (FDA) announced the following actions taken in its ongoing response effort to the COVID-19 Coronavirus pandemic Friday, July 24th, 2020.
Coronavirus
FDA Coronavirus (COVID-19) Update: July 24th, 2020
July 24, 2020
Silver Spring, MD – The U.S. Food and Drug Administration (FDA) has announced the following actions taken in its ongoing response effort to the COVID-19 Coronavirus pandemic:
Today, the FDA updated the Testing Supply Substitution Strategies slide show.
Coronavirus.
FDA Coronavirus (COVID-19) Update: July 23rd, 2020
July 23, 2020
Silver Spring, MD – The U.S. Food and Drug Administration has announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
FDA created a new website section about COVID-19 for people with cancer and health care professionals to highlight FDA resources and how FDA is working diligently to meet the needs of this vulnerable community during this critical time.
Coronavirus
FDA Coronavirus (COVID-19) Update: July 22nd, 2020
July 22, 2020
Silver Spring, MD – The U.S. Food and Drug Administration (FDA) has announced the following actions taken in its ongoing response effort to the COVID-19 Coronavirus pandemic:
A new FDA Voices, tilted FDA’s Ongoing Work to Support and Advance COVID-19 Diagnostic Test Accuracy and Availability, describes how FDA has been proactive and supportive of test development by all comers — including laboratories, and large and small commercial manufacturers — to speed development and to quickly authorize tests that the science supports.
Coronavirus
FDA Coronavirus (COVID-19) Update: July 21th, 2020
July 21, 2020
Silver Spring, MD – The U.S. Food and Drug Administration has announced the following actions taken in its ongoing response effort to the COVID-19 Coronavirus pandemic:
The FDA reissued an Emergency Use Authorization (EUA) to Quest Diagnostics for its Quest SARS-CoV-2 rRT-PCR test, which is now authorized for use with pooled samples containing up to four individual upper-respiratory swab specimens collected under observation.
Coronavirus
FDA Coronavirus (COVID-19) Update: July 18th, 2020
July 18, 2020
Silver Spring, MD – The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 Coronavirus pandemic:
As part of the FDA’s effort to protect consumers, the agency issued warning letters to operators of two websites (www.hydroxychloroquine-online.com and www.pharmaboosters.com) that market unapproved COVID-19 Coronavirus products.
Coronavirus
FDA Coronavirus (COVID-19) Update: July 17th, 2020
July 17, 2020
Silver Spring, MD – The U.S. Food and Drug Administration (FDA) today announced the following actions taken in its ongoing response effort to the COVID-19 Coronavirus pandemic:
At 8:00pm on Friday, July 17th, 2020 the FDA will close its COVID-19 Industry Hotline.
Coronavirus
FDA Coronavirus (COVID-19) Update: July 16th, 2020
July 16, 2020
Silver Spring, MD – The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 Coronavirus pandemic:
Today, the Food and Drug Administration (FDA) updated its Frequently Asked Questions on Testing for SARS-CoV-2.
Coronavirus.
