FDA Newswatch
Coronavirus (COVID-19) Update: FDA Provides Updated Guidance to Address the Urgent Need for Blood During the Pandemic
02 Apr 2020 16:54:38 UT
/PRNewswire/ -- As part of the 's ongoing commitment to fight the Coronavirus Disease 2019 (COVID-19) pandemic, today the agency issued guidance for immediate implementation to address the urgent and...
FDA authorizes first coronavirus antibody test
02 Apr 2020 16:53:28 UT
The US Food and Drug Administration has issued its first emergency use authorization for a coronavirus test that looks for antibodies in the blood. That type of test, called a serology test, would...
FDA loosens restrictions on gay men who donate blood
02 Apr 2020 16:52:41 UT
The agency made the announcement on Thursday. The Food and Drug Administration on Thursday said it would loosen some of the restrictions that have blocked gay men from donating blood. The...
FDA eases blood donation restrictions for gay men, others amid shortage
02 Apr 2020 16:50:09 UT
WASHINGTON -- Facing an urgent need for blood donations, the Food and Drug Administration has relaxed rules restricting blood donations from gay men and other groups. Men who have sex with another...
FDA loosens restrictions on gay men donating blood amid pandemic
02 Apr 2020 16:44:00 UT
The federal government is loosening restrictions on blood donations from gay and bisexual men in light of a blood shortage brought on by the coronavirus pandemic. In revised guidelines published...
FDA Commissioner Approves Coronavirus Antibody Test Produced By Cellex Inc., The First Of Its Kind
02 Apr 2020 16:42:49 UT
Food and Drug Administration Commissioner Stephen Hahn announced Thursday the approval of a coronavirus antibody testing system produced by Cellex Inc., the first of its kind approved for use by FDA....
Amarex, an NSF International Company, Executes Five Rush COVID-19 Related Submissions to the FDA
02 Apr 2020 16:42:04 UT
GERMANTOWN, Md. – In early March 2020, Amarex Clinical Research LLC,...
FDA commissioner announces authorization of coronavirus test that identifies past infections
02 Apr 2020 16:41:54 UT
The commissioner for the Food and Drug Administration announced that a new antibody test had been authorized for determining previous cases of COVID-19. Commissioner Stephen Hahn announced on...
Pittsburgh scientists develop possible coronavirus vaccine, hope FDA can fast-track it
02 Apr 2020 16:40:45 UT
A potential vaccine against the novel coronavirus causing the covid-19 outbreak has been created in a University of Pittsburgh lab. Researchers say the first phase of human clinical trials — which...
FDA sends warning letter to CBD firm over coronavirus claims
02 Apr 2020 16:40:14 UT
The warning letter, dated March 31, was sent to a company called NeuroXPF in Las Vegas, NV.  The company was founded by former NFL player Kyle Turley.  The company’s CBD products include capsules,...
BREAKING NEWS: FDA reducing deferral period for MSM donating blood and plasma from 12 to 3 months
02 Apr 2020 16:37:52 UT
The Gay and Lesbian Alliance Against Defamation today applauded a just-released decision by the U.S. Food and Drug Administration to reduce the deferral period for men who have sex with men donating...
FDA to Fast-Track COVID-19 Therapies Modern Healthcare
02 Apr 2020 16:37:49 UT
The U.S. Food and Drug Administration is fast-tracking drugs to treat COVID-19. This...
FDA clears RapidPoint 500e Blood Gas Analyzer for critically ill
02 Apr 2020 16:31:41 UT
— Siemens Healthineers announced that its RapidPoint 500e Blood Gas Analyzer has received clearance from the FDA. The analyzer generates blood gas,...
FDA Updates Enforcement Discretion Policy For Gowns, Gloves, and Other Apparel
02 Apr 2020 16:29:10 UT
FDA took action earlier this week to relax regulatory standards for gowns, hoods, and surgeons’ and patient examination gloves during the pandemic.  The policy applies to the following products:...
FDA changes boost alcohol for sanitizer from ethanol makers
02 Apr 2020 16:27:19 UT
FDA loosened regulations on what kinds of alcohol can be used to manufacture hand sanitizers in response to the COVID-19 pandemic. FDA says ethanol made at factories that produce fuel ethanol can be...
FDA approves additional treatment for adults and adolescents with hemophilia A or B and inhibitors
02 Apr 2020 16:27:18 UT
FDA on Wednesday approved coagulation factor VIIa (recombinant)-jncw (Sevenfact—Laboratoire Francais du Fractionnement et des Biotechnologies S.A.) for the treatment and control of bleeding episodes...
FDA requests removal of all ranitidine products from the market
02 Apr 2020 16:27:18 UT
FDA on Wednesday ordered that manufacturers immediately pull all prescription and OTC ranitidine (Zantac) medications from the market. The decision is the latest step in the agency's ongoing...
FDA Orders Heartburn Drug Zantac to be Pulled From Market Immediately
02 Apr 2020 16:27:17 UT
The U.S. Food and Drug Administration has asked manufacturers of the drug ranitidine (better known as Zantac ) to pull all of its prescription and over-the-counter products that contain the drug from...
Distillers urge FDA to revisit regulations on production of hand sanitizer
02 Apr 2020 16:23:56 UT
When panicked shoppers purchased inordinate amounts of hand sanitizer, grocery store shelves across the nation were left without one of the key products needed in the fight against the spread of...
BREAKING: FDA eases ban on gay blood donations amid coronavirus crisis
02 Apr 2020 16:23:38 UT
The FDA has changed in policy on gay blood donations. Faced with tremendous pressure during the coronavirus...

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