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FDA's role under the guidelines is to monitor company recalls and assess the adequacy of a firm's action. After a recall is completed, FDA makes sure that the product is destroyed or suitably reconditioned and investigates why the product was defective. Generally, FDA accepts reports and other necessary recall information submitted by e-mail.
Some federal health websites and reports have reappeared after the Trump administration ordered a pause on public communications from agencies like the CDC, FDA, and NIH in January.
Levetiracetam, sold under the brand name Keppra among others, is a novel antiepileptic drug [7] used to treat epilepsy. [8] It is used for partial-onset , myoclonic , or tonic–clonic seizures, [ 7 ] and is taken either by mouth as an immediate or extended release formulation or by injection into a vein .
A drug recall removes a prescription or over-the-counter drug from the market. Drug recalls in the United States are made by the FDA or the creators of the drug when certain criteria are met. When a drug recall is made, the drug is removed from the market and potential legal action can be taken depending on the severity of the drug recall. [1]
Gilead Sciences Inc. (NASDAQ:GILD) has voluntarily recalled one lot of its COVID-19 treatment, Veklury (remdesivir), for Injection 100 mg/vial, after discovering glass particles in the vials. The ...
The FDA is advising consumers not to use these 27 eye drop products after uncovering unsanitary conditions at a manufacturing facility.
Ensitrelvir has been investigated for use as potential post-exposure prophylaxis (PEP) for SARS-CoV-2 infection. [20] [21] The SCORPIO-PEP trial, a global Phase 3 study, assessed the safety and efficacy of ensitrelvir in preventing symptomatic COVID-19 among household contacts of individuals with confirmed SARS-CoV-2 infection.
The Food and Drug Administration will authorize the emergency use of the antiviral remdesivir on COVID-19 patients as soon as Wednesday, a senior administration official told The New York Times.