Search results
Results from the WOW.Com Content Network
The following are settlements reached with US authorities against pharmaceutical companies to resolve allegations of "off-label" promotion of drugs. Under the Federal Food, Drug, and Cosmetic Act, it is illegal for pharmaceutical companies to promote their products for uses not approved by the Food and Drug Administration (FDA), and corporations that market drugs for off-label indications may ...
The FDA issued warning letters to seven companies for selling products that claim to prevent, treat or cure COVID-19 caused by the new coronavirus. The FDA issued warning letters to seven ...
An Emergency Use Authorization (EUA) in the United States is an authorization granted to the Food and Drug Administration (FDA) under sections of the Federal Food, Drug, and Cosmetic Act as added to and amended by various Acts of Congress, including by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), as codified by 21 U.S.C. § 360bbb-3, to allow the use of a ...
[52] [53] [54] As of July 2021, a large number of drugs had been considered for treating COVID-19 patients. [55] As of November 2022, there was moderate-certainty evidence suggesting that dexamethasone, and systemic corticosteroids in general, probably cause a slight reduction in all-cause mortality (up to 30 days) in hospitalized patients with ...
Idaho health department spokesperson AJ McWhorter declined to comment on “public health district business,” but noted that COVID-19 vaccines are still available at community health centers for ...
Late Friday night, the U.S. Food And Drug Administration approved the first coronavirus test that can be conducted entirely at the point of care for a patient and deliver results in 45 minutes ...
Before a drug can be prescribed, it must undergo the FDA's approval process. While a drug can feasibly be used off-label (for non-approved indications), it still is required to be approved for a specific disease or medical condition. [2] Drug companies seeking to sell a drug in the United States must first test it.
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.